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WHO WE ARE Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client’s business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges. The Role: Image Curation and Data products team transforms biomedical imaging data from clinical trials and RWD, by applying the tools and workflows to deliver high quality, FAIR imaging data sets enabling imaging data scientists to discover and utilize for exploratory use to algorithm development. This position is for a Sr. Data manager/ Data architect / Data engineer lead, to join this global team of Imaging data managers to realize the product vision and value. Key Responsibilities: • Imaging Data Pipeline delivery: Design, implement and maintain automated pipelines for onboarding, verifying, transforming and curating biomedical imaging data from clinical trials and real world data sources, for therapeutic areas, Oncology, Neurology, Ophthalmology covering all image file formats., • Data Quality and Integrity: Develop and implement solutions to detect and correct anomalies and inconsistencies, to achieve highest data quality of the imaging data set, per industry standards DICOM, and internal specifications like FFS, RTS, GDSR, etc. Ensure de-identification, PHI/PII controls, and image specific QC checks are implemented at scale., • Data Analysis and integration: Integrate ML and AI assisted tools in the pipelines for inline image analysis, classifications, segmentations, to extract and enrich metadata for various analyses, optimize performance etc.., • Image Data Management: Build and maintain large scale catalogs of curated imaging data sets enhancing FAIR principles, and providing easy to discover and access imaging data assets.., • Compliance and Controls: Ensure applicable compliance and privacy controls are followed as required GXP, CSV validations., • Collaboration: Working closely with Image scientists, data scientists, clinops, and biomarker research teams, supporting data needs for various primary and secondary endpoint analyses., • External collaboration: Work with external partners e.g. CROs in ensuring the imaging data received conforms to the established agreements and quality standards and complete., • Lead to the delivery team to ensure timely delivery of product backlog / features, • Participate with the team and lead various agile ceremonies throughout the planning and execution. Ideal candidate would have, (multiple competencies from list below); • Worked with medical imaging data and platforms , PACS, VNAs etc., • Worked with imaging Radiology data e.g. CT, PET, MRI, nifti and Ophtha imaging OCT, FA,CFP etc., • Good understanding of DICOM standard, structure, metadata parsing, tags, multi-frame images, • Worked with Clinical information data standards like, SDTM, ADaM, • Data integration across diverse data sources, e.g. imaging data with tabular clinical data, • De-identification methodologies, PHI/PII detection and privacy controls, • Good understanding of GXP and CSV validation frameworks, • Proficient in Python, its libraries : pandas, pydicom, SimpleITK, dicom-numpy, dcm2niix, • Hands on experience with ETL/ELT involving large medical imaging datasets, • Apache Airflow, Spark, Talend or similar orchestration of complex workflows., • Proficiency with SQL and noSql, and image meta data stores. (PostgreSQL, Mongo Etc), • Practical experience with AWS infrastructure Data services, e.g. RDS, Athena, Glue, EC2 Lambda, S3 …., • Familiar with EKS, Docker, and HPC, • Experience in data analysis and report generation, e.g Tibco, Tableau, AWS Quicksite etc, • Good knowledge of Git, Gitlab and DevOps tools like Jenkins, Terraform, • Familiar with using ML workflows for Computer Vision tasks like segmentation, classification, etc.., • Nice to have: implemented solutions on NLP and GenAI, • Worked with cross functional global teams in a dynamic Agile environment, • Lead and mentor agile team members., • Has 10+ years of experience with data platforms, analysis and insights Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently. NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job DescriptionAbout Us Optopax is a Silicon Valley–based design and OEM manufacturing company delivering integrated AI imaging solutions—from concept through prototyping to production. We specialize in AI‑enabled camera modules, high‑precision optics across UV to LWIR, and custom embedded systems powering robotics, industrial vision, submersible imaging, biomedical devices, AR/VR optics, medical and optical computing. Join our small, global team headquartered in San Jose, CA on a mission to engineer and manufacture camera solutions that transform how machines see, through custom optics, sensor integration, and embedded imaging platforms. About the Role We are seeking a Director of Engineering to lead our multidisciplinary mechanical, electrical, and optical engineering teams, reporting directly to the CEO & CTO. This role requires a blend of strategic leadership and hands-on technical expertise. The successful candidate will be responsible for defining technical strategy, implementing scalable systems and processes, and directly overseeing the delivery of high-performance imaging products. We are open to remote candidates within the US, with a preference for Bay Area candidates to work on-site alongside the Executive Management team in San Jose, CA. Candidates who cannot engage deeply with the technical aspects of the business will not be a good fit for this position. What You’ll Do • Lead and mentor a cross-functional global team of engineers, • Own the technical execution from architecture through prototyping, integration, and production., • Guide high-impact tradeoff decisions, risk mitigation plans, and quality standards. Manage complex technical negotiations with the senior management team and customers., • Collaborate cross-functionally with sales, operations, and quality to align engineering execution with business needs., • Interface with clients to scope technical needs, lead project execution, and ensure high satisfaction., • Champion engineering excellence, inclusive leadership, and a culture of continuous learning.What You’ll Bring, • Proven leadership in multidisciplinary hardware teams, ideally including both individual contributor and managerial experience., • Direct experience shipping optical or opto-electronic systems from concept to production., • Strong technical background in optical and/or electro-mechanical engineering, with ability to go deep when needed. Hands-on leadership experience is necessary in this role., • Ability to translate complex technical problems into clear decisions and roadmaps., • Excellent communicator who thrives in evolving, fast-paced environments., • Commitment to fostering diverse perspectives and inclusive engineering cultures.Bonus If You Have, • Experience with optical simulation tools (e.g., Zemax, Code V) or building optical components and test stations., • Background in embedded vision, sensors, or regulated product development., • Familiarity with small-batch, high-performance manufacturing environments.

Job DescriptionAbout Us Optopax is a Silicon Valley–based design and OEM manufacturing company delivering integrated AI imaging solutions—from concept through prototyping to production. We specialize in AI‑enabled camera modules, high‑precision optics across UV to LWIR, and custom embedded systems powering robotics, industrial vision, submersible imaging, biomedical devices, AR/VR optics, medical and optical computing. Join our small, global team headquartered in San Jose, CA on a mission to engineer and manufacture camera solutions that transform how machines see, through custom optics, sensor integration, and embedded imaging platforms. About the Role As a Senior or Manager‑level Optical Design Engineer (depending on experience), you’ll lead the development of advanced optical systems—taking ideas from simulation through validation and integration into Optopax’s end‑to‑end imaging platforms. You’ll drive innovation and help strengthen our capabilities in photonics, AI cameras, and embedded vision. We are open to remote candidates within the US with a preference for Bay Area candidates to work on-site alongside the Executive Management team in San Jose, CA. What You’ll Do • Lead design, simulation, tolerancing, and optimization of complex optical systems using tools such as Ansys Optics Studio (Zemax), Code V, LightTools, Lumerical, Quadoa, or equivalent., • Perform stray‑light, ray‑trace, wavefront, photon budget, and design for manufacturability (DFM) analyses (e.g., Monte‑Carlo tolerancing)., • Translate customer specifications into detailed design requirements; collaborate across mechanical, electrical, firmware/software, and manufacturing teams for system integration and prototyping., • Guide validation of designs via lab testing, metrology, and performance measurement (e.g., MTF, distortion, SNR, wavefront)., • Mentor and support junior optical engineers and cross‑functional partners, establishing design best practices and documentation., • Drive innovation through research into new optical technologies, materials, coatings, and manufacturing techniques, informing future product strategies., • Drive critical technical communications / negotiations with customers to ensure optical solutions align with performance, cost, and manufacturability goals.What You’ll Bring Required • Master’s or PhD in Optical Engineering, Physics, or a related field., • Minimum 5+ years experience in optical design and engineering—ideally handling advanced, multi‑element systems., • High proficiency with optical design and simulation tools (e.g., Zemax, Code V and others)., • Strong fundamentals in geometrical and physical optics design methodology, optical fabrication techniques, DFM, tolerancing, and metrology., • Experience in design documentation and cross-functional collaboration.Preferred, • Background in imaging systems for robotics, embedded cameras, LWIR, biomedical, AR/VR, sensors, or AI vision modules (reflecting Optopax’s core markets)., • Exposure to prototyping processes including wafer‑level optics, active alignment, cleanroom assembly, or rapid prototyping workflows., • Familiarity with optical test stations or imaging qualification methods (a pillar of Optopax’s product offerings)., • Experience in team leadership or mentoring, and process improvement with a proven track record of success, • Programming or scripting skill (MATLAB, Python) for automation of analyses or data processing.

Job Description DeepSight Technology Inc. is a stealth mode startup company that has developed breakthrough technology in ultrasound imaging. This new technology will both extend the range and clarity over current systems by 10x - 100x! We are setting new standards that will dramatically improve the capabilities of ultrasound for many years. In order to develop and improve this technology, we need dedicated team members. Not only do we offer a great team-oriented environment, but we also offer competitive compensation of $150,000-$250,000 per year and generous benefits in both our St. Louis, MO and Santa Clara, CA offices. Job Description We are looking for an Engineer with a strong background in Ultrasound Image Analysis to work on our new ultrasound imaging platform. This is a crucial role in our design and development process. As the Image Analysis Engineer, your responsibilities are: • Lead image analysis from probe bring-up to final optimization, • Lead ultrasound imaging feature definition, development, implementation, and verification to ensure successful product release., • Reconcile image artifacts with the development team to resolve system performance leading to the highest quality imaging for the company, • Development of image performance parameters that result in maximizing the ultrasound system and probe performance, • Image optimization based on tissue characterization and blood flow visualization and quantification., • Taking ownership of image quality, system performance verification, engineering and clinical image optimization, and customer support., • Developing and using imaging tools to verify image feature development for transfer to software implementation, • Driving innovation and continual improvement of imaging performance all the way from concept generation to prototyping and product implementation., • M.S. in Electrical/Biomedical Engineering, • 7+ years industry experience in medical imaging product development, • Expertise in ultrasound physics and system design, signal and image processing, algorithm specification and development, • Demonstrated experience using MATLAB/Python for fast prototyping; C/C++ programming, • Demonstrated technical abilities in coordinating development efforts of a highly technical group, • Excellent oral and written communication skills, • Able to adapt quickly to change and work in a rapidly evolving environment, • Willing to relocate to either the St. Louis, MO or Santa Clara, CA areas, • PhD in Electrical/Biomedical engineering with a dissertation topic related to ultrasound imaging or therapy, • Positive - a can-do attitude that helps you rise to challenges, • Collaborative - a team player who can effectively communicate with others, • Attentive to detail - nothing gets by you, • Efficient - a knack for effectively prioritizing tasks and managing your time, • Pride in your work - real desire to do quality work, • Career-minded - looking for more than a job We offer great benefits and perks: • Competitive salary, • Stock options, • Medical, dental, and vision insurance, • 401(k) retirement plan Job Posted by ApplicantPro

Job Description About Ceribell Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement! Position Description Ceribell is looking for a Senior Firmware Engineer / Senior Embedded Engineer who is passionate about biomedical applications and who has experience in the development of embedded or IoT products. The successful candidate will join the R&D team and will play a key role in the development of the next generation of Ceribell's life saving technologies. Our firmware development stack is based around a STMicroelectronics STM32 ARM Cortex microcontroller and we use FreeRTOS, the IAR Embedded Workbench, and the TouchGFX framework. You must be able to work collaboratively as part of a cross-functional R&D team, but you must also be able to take individual ownership for development, testing, and documentation of your projects. Ceribell is looking for a Staff Embedded Linux Software Engineer who is passionate about biomedical applications and who has experience in the development of embedded Linux-based products. The successful candidate will join the R&D team and will play a key role in the development of the next generation of Ceribell's life saving technologies. You must be able to work collaboratively as part of a cross-functional R&D team, but you must also be able to take individual ownership for development, testing, and documentation of your projects. What you'll achieve • Develop, test, and maintain software features for Ceribell's EEG systems., • Work with cross-compilation toolchains, build systems (Yocto, Buildroot, or similar), bootloaders, and CI/CD pipelines., • Develop, integrate, and debug device drivers for various peripherals (I²C, SPI, UART, USB, PCIe, etc.)., • Troubleshoot and resolve complex issues across the software/hardware boundary., • Understand user needs and translate them to the development of new and improved features., • Participate in code reviews, peer reviews, and risk management activities., • Provide input on firmware and hardware architecture for new and existing products.What you'll need to be successful, • Bachelor's Degree in electrical engineering, computer science, biomedical engineering or related field. Graduate degree preferred., • 10+ years of experience in embedded software development of a commercial product. Medical device experience preferred., • 3+ years of professional experience in embedded Linux software development, interfacing with peripherals, and configuring device drivers and associated toolchains, e.g. Ubuntu, Torizon, Yocto, Buildroot., • Experience with bootloaders (U-Boot, security-boot), and system startup., • Experience with GUI-based application development in e.g. Qt preferred., • Experience using Git for version control., • Proficient in C/C++., • Direct experience with development of WiFi connected/IoT devices preferred., • Strong analytical skills, detail-oriented and collaborative. In addition to your base compensation, Ceribell offers the following: • Annual Bonus + Equity Opportunity, • 100% Employer paid Health Benefits for Employees, • 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection), • 100% paid Life and Long-Term Disability Insurance, • 401(k) with a generous company match, • Employee Stock Purchase Plan (ESPP) with a discount, • Monthly cell phone stipend, • Flexible paid time off, • 11 Paid Holidays + 5 Company Wellness Days, • Excellent parental leave policy, • Fantastic culture with tremendous career advancement opportunities, • Joining a mission-minded organization!Compensation Range$175,000—$200,000 USD

Job Description About Ceribell Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement! Position Overview: We are seeking a detail-oriented and highly skilled Medical Device Software Quality Engineer to join our Quality Assurance team. The engineer will be responsible for championing quality assurance throughout the software development lifecycle, ensuring that all processes adhere to high standards and corporate requirements. The successful candidate will play a key role in ensuring the quality, safety, and compliance of software used in medical devices. You will work closely with software engineers, product managers, and regulatory teams to define and execute quality processes and activities that meet industry standards and regulatory requirements, including FDA Design Controls CFR 820.30, IEC 62304 – Software in a Medical Device, IEC 82304 – Software as a Medical Device, IEC 14971 – Risk Management, ISO 13485 – Quality Management Systems, 2017/745 – European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, and General Principles of Software Validation. This role will also assist on maintaining quality systems, supporting Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCR), complaints, audits, and overall Quality Management System (QMS) functions. What you'll do: • Act as a champion of Quality Assurance throughout the software development lifecycle, ensuring adherence to high standards and corporate requirements., • Develop and implement quality assurance processes for medical device software development, ensuring compliance with FDA, ISO 13485, IEC 62304, and other relevant standards., • Collaborate with software engineers, hardware engineers, and cross-functional teams to review design specifications, requirements, and software documentation for compliance with quality standards., • Conduct software risk assessments and contribute to risk management activities, including hazard analysis, FMEA (Failure Modes and Effects Analysis), and software safety analysis., • Develop and execute software verification and validation (V&V) plans to ensure software functionality, performance, and safety meet required standards., • Lead software quality audits and reviews, ensuring adherence to quality systems, processes, and regulatory requirements., • Ensure proper documentation and traceability of quality activities, including test plans, test cases, defect reports, and validation protocols., • Support the preparation and review of regulatory submissions, such as 510(k) filings or CE marking applications, ensuring the software quality processes are adequately documented., • Troubleshoot and manage software-related quality issues, working closely with development teams to resolve defects and improve software reliability., • Participate in design control activities to ensure software quality throughout the product lifecycle, including planning, development, testing, and post-market surveillance., • Assist in the training and development of team members on software quality standards, best practices, and regulatory requirements., • Bachelor's degree in Computer Science, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical field (Master's preferred), or equivalent experience., • Minimum of 8 years of software quality engineering, experience in planning, creating and executing test cases particularly in medical device development with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience., • Strong knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971., • Experience in software verification and validation processes for embedded software and medical device software systems., • Strong understanding of software development life cycle (SDLC) and best practices for quality assurance and control., • Familiarity with programing language, software test tools, automated testing, and defect management systems., • Excellent problem-solving, analytical, and troubleshooting skills., • Strong attention to detail with a commitment to delivering high-quality, compliant products., • Excellent written and verbal communication skills, with the ability to work collaboratively in a cross-functional team environment., • Strong interpersonal skills including the ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team., • Experience with risk management practices, including risk analysis and mitigation strategies., • Experience with software quality systems for Class II or III medical devices., • Familiarity with AI/ML based medical device software quality management., • Familiarity with FDA software validation, design controls, and regulatory submission requirements (510(k), PMA)., • Experience with software tools such as JIRA, TestRail, or similar defect tracking and test management platforms., • Experience with agile development methodologies and software development tools., • Annual Bonus + Equity Opportunity, • 100% Employer paid Health Benefits for Employees, • 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection), • 100% paid Life and Long-Term Disability Insurance, • 401(k) with a generous company match, • Employee Stock Purchase Plan (ESPP) with a discount, • Monthly cell phone stipend, • Flexible paid time off, • 11 Paid Holidays + 5 Company Wellness Days, • Excellent parental leave policy, • Fantastic culture with tremendous career advancement opportunities For information on how Ceribell processes personal data of job applicants, please review our Privacy Policy. 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Job Description Personalized Medicine, Inc., is an early stage, stealth mode startup looking for a talented engineer to join in the research and development of an innovative bedside monitoring product that is visionary, expecting to integrate real-time data capture with large complex data sets, using Ai/ML recursive algorithms. The following are pre-requisites: • MS or PhD in biomedical engineering or related disciplines, • Must have experience in software and hardware design and development (enterprise, industrial, consumer or medical industries), • Ideal candidate would have both analog and digital hardware experience, • Must have gone through the product lifecycle of at least one hardware product. Must be familiar with power/thermal budget tradeoffs and reliability testing., • Experience with wearables and power/CPU constrained design would be a plus, • Experience with microelectronics, medical devices and sensors would be a strong plus, • Solid understanding and experience with methodologies using topological modeling of large complex data sets, • Startup experience and/or entrepreneurial mindset Please submit your CV and cover letter. Subbu Ponnuswamy, CEO Company Descriptionearly-stage startup working with experienced CTO in Bay Areaearly-stage startup working with experienced CTO in Bay Area

Job DescriptionDescriptionThe 3D Printing Process team at Align Technology is looking for a 3D Process Engineer III at the San Jose, CA, location. This on-site role focuses on hands-on experimentation and process development within a lab setting. The ideal candidate will lead efforts to create, refine and enhance 3D printing and post-processing techniques, while also supporting R&D initiatives for emerging materials and product concepts. This position offers a unique opportunity to collaborate across software, materials, and design teams to address complex challenges in additive manufacturing. Role expectations • Independently operate new additive manufacturing equipment and post processing equipment., • Perform material and product testing using standard and non-standard material testing equipment., • Collect, maintain and organize data in accordance to internal standards and quality requirements., • Participate, and lead select weekly and bi-weekly technical meetings with cross functional groups, • Present data, findings, and ideas to the process and cross-functional teams on a weekly basis, • Use statistical tools to analyze, interpret, and present experiment results., • Be responsible for writing, maintaining, and transferring work instructions to manufacturing teams., • Be responsible for writing, maintaining and supporting protocols for process and equipment qualifications and process transfer., • Be responsible for writing and maintaining work instructions for Process R&D activities., • Work closely with cross functional collaborators to support and to receive support on major project milestones., • Learn and apply the use of design for additive manufacturing (DFAM) principles to support printing and post process development., • Learn and apply process-structure-property relationship exploration to study, and tune process to match desired performance and accuracy metrics., • Operate, collect and analyze data from polymer characterization equipment to support process-structure-property explorations., • Independently design, setup and execute experiments to study process-structure-property relationships for polymer AM systems for the purpose of understanding/optimizing the manufacturing process., • Collaborate with the Manager, peers and cross functional groups (as necessary) to design experiments and identify deliverables., • Use and develop methods to collect, process and analyze data from advanced metrology techniques like CT, CMM and similar appliances, • Be responsible for collection, processing and analysis of orthodontic performance data for exploring the relationship between process and performance., • Create, evaluate, support prototyping of equipment, jigs, fixture and tools necessary for manufacturing process internally or with external support., • Maintain vendor relationships and be responsible for design review and release of custom equipment., • Study and develop metrics to explore the process capability of end-to-end pilot manufacturing process for R&D products., • Responsible for supporting the planning, execution and documentation of experiment results and analysis for regulatory submissions., • Responsible for serving as SME for internal and external audits related to process development and optimization., • Support the creation of requirements for manufacturing software such as support generation, slicing, layout etc., • Serve as a technical liaison for manufacturing software development, prototyping (coding, code editing), and testing., • Support in test method validation for critical quality monitoring steps., • Support generation of quality metrics and acceptance criterion for inspection and other in-process monitoring steps., • Support and participate in calibration, spirit committee, and safety programs., • Serve as lead for training and transfer of process work instructions and protocols for pilot lines., • Foster collaboration with cross functional teams, support onboarding and training of technicians., • Work in a fast-paced environment and meet critical deadlines, • Problem solve issues with attention to detail, • MS degree in mechanical or Biomedical Engineering (other scientific disciplines considered) with 3-4 years of direct 3D printing experience related to SLA/ Resin based 3D printing machines, or printed medical devices., • PhD degree in mechanical or relevant interdisciplinary degree with focus on process or post process development for photopolymer based additive manufacturing systems, • Experience with handling and working with chemicals such as Iso propyl alcohol, photopolymers, cleaning agents., • Knowledge/ Fundamentals of Process Design for Additive Manufacturing., • Experience in development of printing or post process parameters for a specific application or material., • Working/Practical knowledge of polymer process-structure-property relationships in the context of manufacturing., • Experience in optimizing post process parameters for 3D printed parts, • Experience using instruments such as CT scanners, Surface profilers, Digital microscopes and similar imaging techniques., • Demonstrable experience highlighting the use of statistical techniques (e.g. DOE) to analyze data and control variation in manufacturing process, • Demonstrable experience in collaboration with multidisciplinary teams, • Demonstrable experience in troubleshooting problems with logical approach., • Demonstrable experience in presenting technical data with strong communication skills., • Experience using CAD/3D modeling packages like solidworks, inventor etc. Nice to Have:, • Experience in development of metrics for process control and process capability., • Collaboration with polymer design/engineering groups is desirable., • Experience scaling processes beyond R&D lab/ desktop phase., • Experience using AM tools such as slicer and other toolpath generation SW., • Experience with SW tools and coding languages such as JMP, Python, MATLAB etc., • Experience with building/operating custom 3D printers, material testing, or post processing equipment.

Job Description Your main responsibilities as a Systems Engineer (Software Integration and Testing): • System Lifecycle Management: Apply broad knowledge and skill-sets from Systems Engineering, focusing on the software integration and testing stages of the system lifecycle., • Industry and Technology Analysis: Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for software differentiation and creative solutions., • Cross-functional Collaboration: Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements., • Customer-Focused Innovation: Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize software features and enhancements., • Technical Problem Solving: Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address software integration and testing challenges. What we are looking for in a Systems Engineer (Software Integration and Testing): • Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master’s degree with 2 years of experience, or a PhD)., • Systems Engineering Expertise: Demonstrated knowledge of systems engineering principles, specifically in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation., • Regulatory Familiarity: Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products., • Strategic Mindset: Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD. As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r\n\r\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\r\n\r\nOur life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

Job Description About DeepSight Technology DeepSight Technology is a leading innovator in medical device technology, specializing in advanced ultrasound solutions like enhanced needle guidance with NeedleVue™, high-resolution imaging from the tip of a needle with OnPoint™ Imaging, and superior diagnostic capability with the EchoLux™ Ultrasound system. Our mission is to revolutionize patient care through state-of-the-art systems, oIering unprecedented precision and accuracy for healthcare providers. Job Summary The Instrument Engineer will lead the design, prototyping, and optimization of DeepSight's interventional instruments. This role takes concepts from ideation to prototype, ensuring seamless integration into clinical applications. The ideal candidate excels in medical device development, rapid prototyping, and regulatory compliance, working cross-functionally with R&D, clinical, and manufacturing teams. Key Responsibilities • Develop interventional devices such as catheters, guidewires, venous access tools, biopsy instruments, and therapy delivery systems., • Design, prototype, and test instruments, fixtures, and assemblies., • Build and iterate proof-of-concept devices for pre-clinical testing., • Initiate and maintain the Device Master Record through development, including:, • Drawings, specifications, and BOMs, • Process instructions, test methods, and specifications, • Fixtures, tooling, and material selection, • Identify and collaborate with contract manufacturers and suppliers for sub-assemblies and production., • Work with clinical experts to ensure procedural requirements and constraints are incorporated into the instrument design., • Apply expertise in Advanced Manufacturing Techniques:, • Lamination, extrusions, coiling, and braiding, • Steering and bending sections, • Bonding, adhesion technologies, and techniques, • Laser cutting, welding of fine structures, EDM, and water jet machining, • Ensure compliance with ISO 13485, ISO 60601, ASTM, and other relevant standards., • B.S. or M.S. in Mechanical or Biomedical Engineering or related field., • 10+ years of experience in instrument engineering or medical device development., • Proficiency in CAD for device design and documentation., • Experience with medical device fabrication techniques (lamination, laser cutting, bonding, etc.)., • Knowledge of interventional devices (catheters, guidewires, biopsy tools, etc.)., • Familiarity with regulatory standards (ISO 13485, ISO 60601, ASTM)., • Strong hands-on prototyping skills and ability to rapidly iterate designs., • Experience collaborating with contract manufacturers and suppliers. At DeepSight Technology, you'll be part of a team that's pushing the boundaries of ultrasound imaging and medical device innovation. This is an opportunity to develop groundbreaking instrumentation, collaborate with top engineers and clinicians, and impact the future of healthcare. Job Posted by ApplicantPro

Job Description Staff Software Engineer, GPU Algorithms We are looking for a full-time Staff Software Engineer, GPU Algorithms with a strong background in ultrasound, medical image reconstruction, and programming languages such as C++ and CUDA to shape our new ultrasound imaging platform. As a Staff Software Engineer, you will work on developing and optimizing GPU algorithms and techniques related to ultrasound signal processing, image formation, and analysis. The primary focus of this software engineering role is to improve the quality, accuracy, and interpretation of ultrasound images for DeepSight's revolutionary Ultrasound system. WE OFFER GREAT BENEFITS AND PERKS TO OUR SOFTWARE ENGINEERING TEAM: • Competitive salary of $170,000-$220,000, • Stock options, • Medical, dental, and vision insurance, • 401(k) retirement plan AS A STAFF SOFTWARE ENGINEER SPECIALIZING IN GPU ALGORITHMS, YOUR RESPONSIBILITIES ARE: • Developing advanced beamforming techniques to enhance the spatial resolution and image quality of ultrasound scans., • Designing algorithms for image enhancement, noise reduction, edge detection, and speckle reduction in ultrasound images., • Developing algorithms for reconstructing 2D or 3D images from acquired ultrasound data. This involves handling data interpolation, scan conversion, and geometric transformations., • Designing algorithms to extract relevant features and perform segmentation of structures or regions of interest in ultrasound images., • Developing techniques to compensate for motion artifacts caused by patient movement or tissue motion during ultrasound scanning. This can involve image registration, motion estimation, and correction algorithms., • Exploring the application of machine learning and artificial intelligence (AI) techniques to improve ultrasound image analysis, automate diagnosis, or assist in image interpretation tasks., • Collaborating with systems and hardware engineers to optimize the integration of ultrasound imaging systems, ensuring efficient data acquisition, processing, and display., • Implement proposed solutions using C++ and CUDA programming languages. REQUIRED QUALIFICATIONS: • BS in an engineering or computer science field, • Familiarity in ultrasound physics, signal and image processing, beamforming, simulation, algorithm development, or tool development, • Strong background in object-oriented programming, software architecture, and design patterns, • Proficiency with C++ programming, • Experience in concurrent/parallel programming-multithreading, multiprocessing, GPU acceleration (CUDA, CuPy, Numba, OpenCL, Halide), • Deep familiarity with common developer tool sets, including source control, continuous integration, and automated unit testing, • Passionate about medical devices, with excellent communication and teamwork skills PREFERRED QUALIFICATIONS FOR THIS SOFTWARE ENGINEERING ROLE: • PhD in Electrical/Biomedical engineering with a dissertation topic related to ultrasound imaging or therapy, • 5+ years of experience in commercial software development, • Experience in medical imaging product development (FDA regulated), • Experience with real-time software applications, • Experience interfacing with hardware components and systems, • Knowledge of DICOM and HL7 QUALITIES WE ARE LOOKING FOR IN THIS STAFF SOFTWARE ENGINEER, GPU ALGORITHMS POSITION: • Positive - a can-do attitude that helps you rise to challenges, • Collaborative - a team player who can effectively communicate with others, • Attentive to detail - nothing gets by you, • Efficient with a knack for effectively prioritizing tasks and managing your time, • Proud of your work and real desire to do quality work, • Career-minded - looking for more than a job, • Empathetic - a mindset of producing quality products that help people JOIN OUR SOFTWARE ENGINEERING TEAM! Ready to take on the challenge? If you've got the drive to succeed and the hustle to make things happen, we're excited to have you join our team! Use our 3-minute initial application to apply now! Job Posted by ApplicantPro

Job DescriptionDescriptionPrecision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices—such as computers and smartphones—with their thoughts alone, opening new possibilities for daily life. Precision’s multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more. We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS. As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation’s top hospitals. We are seeking a Senior Firmware Quality Engineer to help build and test the embedded software that makes our BCI technology possible. In this role you will collaborate cross-functionally with multiple high performing groups of team members that are experienced with working on complex and exciting projects within the medical device and brain-computer interface fields. This position will be based in our Santa Clara, California office. We are unable to consider remote workers or people not currently based in the United States, with working rights. Key Responsibilities • Facilitates and completes design control tasks in collaboration with the Firmware Engineering Team., • Participate in regular Scrum events such as sprint planning, review, and retrospective., • Collaborates with software developers, hardware engineers and regulatory affairs to create integration tests for new features., • Develop, review, and execute test plans, test cases, and test scripts for embedded firmware used in or as medical devices., • Participate in design reviews, risk assessments, and requirements analysis to ensure testability and compliance., • Applies and adheres to IEC 62304/FDA guidance in developing firmware integration protocols/reports., • Use lab equipment (e.g., oscilloscopes, logic analyzers, simulators) to test and debug embedded systems., • Generates and maintains Quality documentation associated with software/firmware engineering., • Completes software level-debug of software components/hardware., • Assists in troubleshooting software problems., • Documents and communicates test results, and track software bugs and their resolution., • Safety is at the heart of our ethos at Precision - and it is for you too. Candidates for this role must have a strong background in software testing; you will be helping build infrastructure for automated system verification. Skills, Knowledge and ExpertiseRequired: • Bachelor’s degree in Electrical Engineering, Computer Science, Biomedical Engineering, or related field., • 3+ years of experience in firmware/embedded software testing., • Experience in medical device development or other regulated industry (FDA, ISO 13485)., • Working knowledge of IEC 62304, ISO 14971, ISO 13485 and FDA and EU guidance and regulations related to medical device software., • Demonstrated scripting ability in Python, • Familiarity with embedded C/C++, real-time operating systems, and hardware-software integration., • Proficient with test tools and frameworks (e.g., Python, CUnit, Jenkins, Jira, TestRail)., • Excellent analytical, troubleshooting, and documentation skills. Preferred: • Experience with automated testing for embedded systems., • Knowledge of risk management per ISO 14971., • Familiarity with cybersecurity and software updates in connected medical devices.Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Johnson & Johnson is hiring for a Principal R&D Engineer (Reducer Catheter) Shockwave Medical to join our team located in Santa Clara, CA. Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's products. Principal R&

TITLE: X-Ray Biomedical Engineer. The Biomedical Engineer plans, trains others, and installs, maintains and repairs sophisticated medical equipment and systems utilized in the diagnosis treatment and monitoring of patients. Must work collaboratively with all other biomedical engineers specialties (I

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease. They are seeking a Sr. R&D Engineer – Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing. DUTIES / EXPECTATIONS OF THIS ROLE · Prepare and present structured technical documentation and summaries for internal and external stakeholders. · Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. · Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). · Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. · Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. · Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. · Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. · Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY · Bachelor’s or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). · 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). · Proven experience authoring and managing requirements, traceability matrix, and risk documentation. · Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. · Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. · Strong attention to detail with a systematic approach to documentation and traceability. · Excellent organizational and communication skills with the ability to manage multiple priorities.

One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt. Function as QA

Job Posting ROCGJP00037416 Client: Roche JOB SUMMARY As a member of the Roche Sequencing Unit's Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This contractor role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. The role operates within a matrix organization, collaborating with cross-functional and multinational teams to ensure compliance, process capability, and product supply integrity. Responsibilities Technical Support: · Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives. · Conduct product and process characterization, including capability studies and identification of critical parameters. · Author and maintain Work Instructions and other production-related documentation in compliance with quality standards. · Design and implement In-Process Controls (IPCs) to monitor CTQs during manufacturing. · Develop and maintain CTQ-Scorecards to track performance against quality attributes. · Lead or support root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone Analysis). · Partner with cross-functional teams for specification development, process characterization, and material qualification. · Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab. Continuous and Process Improvement: · Lead strategic improvement initiatives targeting cost reduction, yield improvement, and process efficiency. · Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., pFMEA). · Collaborate across the Roche network to share and implement best practices. · Quality Mindset: · Ensure compliance with Quality System requirements through document control, change management, and monitoring. · Participate in and support audits, CAPAs, NCRs, and validation of methods and systems. · Other duties as assigned by management. QUALIFICATIONS Formal Training/Education · Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable. Experience · Minimum 5 years in medical device, IVD, or regulated manufacturing roles. · Experience working in a GMP or ISO 13485 compliant manufacturing environment, with direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations · Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred. · Hands-on experience in several of the following areas is highly desirable: · Biosensor or semiconductor manufacturing, especially processes involving functionalized surfaces. · Automated liquid handling, reagent dispensing, and precision fluidics. · Working in a cleanroom environment.? · · Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab). · Prior experience authoring and managing production documentation in ERP systems (e.g., SAP). Knowledge, Skills and Abilities · Strong communication, collaboration, and influencing skills across all levels. · Ability to independently manage technical tasks and projects with minimal supervision. · Demonstrated experience implementing in-process controls and CTQ metrics. · Demonstrated ability with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis. · Familiarity with Lean and Six Sigma principles (Green Belt certification preferred). · Working knowledge of FDA Quality System Regulation (QSR) 21 CFR 820 and ISO 13485 standards. Licenses and Certifications (OPTIONAL) · LEAN/Six Sigma Certification – Green Belt preferred (attainable within 12 months). Travel Requirements Estimated Amount: 10% Brief Description: Domestic and international travel based on business needs.

MS or PhD in biomedical engineering or related disciplines.

Job DescriptionDescriptionAlign Technology’s 3D Printing Process team is seeking a Sr. 3D Process Engineer to join our San Jose, CA location. This in-person role involves hands-on, in-lab research and development focused on advancing additive manufacturing process control. The successful candidate will lead targeted R&D initiatives to solve fundamental process problems, serve as a subject matter expert in additive manufacturing, and collaborate with cross-functional teams to support regulatory submissions, process validation, and technology transfer activities. Role expectations • Independently operate new additive manufacturing equipment and post processing equipment., • Perform material and product testing using standard and non-standard material testing equipment., • Collect, maintain and organize data in accordance to internal standards and quality requirements., • Participate, and lead select weekly and bi-weekly technical meetings with cross functional groups, • Present data, findings, and ideas to the process and cross-functional teams on a weekly basis, • Use statistical tools to analyze, interpret, and present experiment results., • Be responsible for writing, maintaining, and transferring work instructions to manufacturing teams., • Be responsible for writing, maintaining and supporting protocols for process and equipment qualifications and process transfer., • Be responsible for writing work instructions for core Process R&D activities., • Work closely with cross functional collaborators to support and to receive support on major project milestones., • Serve as SME for design for additive manufacturing (DFAM) to support printing and post process development., • Operate, collect and analyze data from polymer characterization equipment to support fundamental research in the area process-structure-property explorations., • Apply your expertise in process-structure-property relationship exploration to study, and tune process to match desired performance and accuracy metrics., • Use and develop methods to collect, process and analyze data from advanced metrology techniques like CT, CMM and similar equipment, • Be responsible for collection, processing and analysis of orthodontic performance data for exploring the relationship between process and performance., • Collaborate with the manager to identify, plan, and assemble core team to support independent R&D topics. Independently design, setup and execute experiments to study process-structure-property relationships for polymer AM systems for the purpose of understanding/optimizing the manufacturing process., • Lead and delegate tasks to Jr. team members and technicians supporting the R&D activities., • Create, evaluate, support prototyping of equipment, jigs, fixture and tools necessary for manufacturing process internally or with external support., • Maintain vendor relationships and be responsible for design review and release of custom equipment., • Study and develop metrics to explore the process capability of end-to-end pilot manufacturing process for R&D products., • Serve as lead for development of acceptance metrics, process performance criterion, and in-process monitoring criterion., • Lead activities related to test method development and validation., • Lead and support the planning, execution and documentation of experiment results and analysis for regulatory submissions., • Serve as SME for internal and external audits related to process development and optimization., • Provide the requirements for manufacturing software such as support generation, slicing, layout etc., • Serve as a technical liaison for manufacturing software development, prototyping (coding, code editing), and testing plan., • Support and participate in calibration, spirit committee, and safety programs., • Foster collaboration with cross functional teams, support onboarding of Jr. engineers., • Work in a fast-paced environment and meet critical deadlines, • Problem solve issues with attention to detail, • MS degree in mechanical or Biomedical Engineering (other scientific disciplines considered) with 6-8 years of direct 3D printing experience related to SLA/ Resin based 3D printing machines, or printed medical devices., • PhD degree in mechanical or relevant interdisciplinary degree with 3-5 years of direct focus on process or post process development for photopolymer based additive manufacturing systems. Experience with AM systems for medical device applications is a bonus., • Demonstrable expertise in statistical analysis and design of experiments, • Demonstrable expertise in leading independent research and troubleshooting problems with logical approach., • Experience with handling and working with chemicals such as Iso propyl alcohol, photopolymers, cleaning agents., • Experience being comfortable with taking risk-based decisions for ambiguous problem statements., • Excellent technical communication skills (technical writing and presentation skills), • Strong mathematical ability to support physical process modelling using experiment observations and results., • Experience using instruments such as CT scanners, Surface profilers, Digital microscopes and similar imaging techniques., • Demonstrable experience in collaboration with multidisciplinary teams Nice to Have:, • Practical coding experience in python or equivalent languages., • Experience with end-to-end development of printing or post process parameters for a specific application or material., • Experience working in a collaborative environment with polymer design/engineering groups., • Experience in development of metrics for process control and process capability., • Experience using AM tools such as solidworks, slicer and other toolpath generation SW., • Experience with building/operating custom 3D printers, material testing, or post processing equipment.

Job DescriptionDescriptionAlign Technology is the industry leader and innovator in medical devices which focuses on revolutionizing the digital dental and orthodontic industry. Align Technology is looking for an R&D Engineer III, Core Product for our San Jose, CA office. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry. The R&D Engineer III, Core Product candidate should have exceptional skills with product research and development in the medical device industry. The R&D Engineer III, Core Product will be the lead engineer responsible for planning, leading, and executing projects focusing on product design and design improvement. They will work closely with internal and external resources in a multidisciplinary team working with materials, software, and manufacturing to conduct research and development in the areas of product performance, design, and improvement. This role will be part of Align Technology’s goal to deliver our clear aligners (Invisalign®) to our customers. Role expectations • Lead product development projects and research projects until product launch, • Work independently to develop and evaluate new products and solutions and adapt and improve existing ones, • Design and evaluate product prototypes with biomechanical test models and experimentation, • Design, build, and verify test hardware, software, and systems as needed, • Define and conduct procedures for bench top testing to evaluate product performance, including efficacy, reliability, verification, and validation, • Work with clinical team to conduct pilot studies and other investigations, • Simulate real world conditions and measure outputs using sensors, • Collaborate with diverse, cross-functional teams to incorporate design and features into prototypes, • Understand and master complex systems with sound mechanical principles, • Define procedures to evaluate product performance and conduct bench top testing, • Responsible for ensuring that testing covers efficacy, reliability, verification, and validation, • Perform statistical data analysis and interpretation, • Perform and document work in accordance with FDA/ISO regulations, including test protocols, test results, and other requirements, • Collaborate with manager and cross-functional team in creating product and test plans, • Communicate with professionals in the field at all levels and transition information into product improvement, • Conceive new product and technology development plans, • Work in a fast-paced environment and meet critical deadlines, • Problem-solve issues with attention to detail, • B.S, M.S., or Ph.D. in Mechanical/Biomedical Engineering or other related degrees/equivalent work experience., • 5+ years of experience in biomedical research and/or product development, • Theoretical and experimental background in structural mechanics and/or biomechanics, • Experience with additive manufacturing and rapid prototyping processes for product design and development, • Experience with 3D modeling using CAD software, Solidworks preferred, • Experience with scripting/programming, • Experience with finite element analysis, • Experience in medical device industry

Job DescriptionDescriptionAlign Technology is the industry leader and innovator in medical devices which focuses on revolutionizing the digital dental and orthodontic industry. Align Technology is looking for a Sr. R&D Engineer, Core Product for our San Jose, CA office. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry. The Sr. R&D Engineer, Core Product candidate should have exceptional skills with product research and development in the medical device industry. The Sr. R&D Engineer, Core Product will be the lead engineer responsible for planning, leading, and executing projects focusing on product design and design improvement. This person is seen as a subject matter expert in the medical device product development and mechanical design related fields. They will work closely with internal and external resources in a multidisciplinary team working with materials, software, and manufacturing to conduct research and development in the areas of product performance, design, and improvement. This role will be part of Align Technology’s goal to deliver our clear aligners (Invisalign®) to our customers. Role expectations • Lead multiple product development projects and research projects until product launch, • Work independently to develop and evaluate new products and solutions and adapt and improve existing ones, • Design and evaluate product prototypes with biomechanical test models and experimentation, while providing in-depth technical analysis and design recommendations for business sensitive solutions, • Design, build, and verify test hardware, software, and systems as needed, • Define and conduct procedures for bench top testing to evaluate product performance, including efficacy, reliability, verification, and validation, • Work with clinical team to conduct pilot studies and other investigations, • Simulate real world conditions and measure outputs using sensors, • Collaborate with diverse, cross-functional teams to incorporate design and features into prototypes, • Understand and master complex systems with sound mechanical principles, • Exercise independent judgment of and define methods, techniques, and evaluation criteria to assess product performance and conduct bench top testing, • Responsible for ensuring that testing covers efficacy, reliability, verification, and validation, • Perform statistical data analysis and interpretation, • Perform and document work in accordance with FDA/ISO regulations, including test protocols, test results, and other requirements, • Collaborate with manager and cross-functional team in creating product and test plans, • Network and communicate with professionals in the field at all levels and transition information into product improvement, • Conceive new product and technology development plans, • Work in a fast-paced environment and meet critical deadlines, • Problem solve issues with attention to detail, • Actively coach, motivate, mentor and provide leadership to peers and Jr. engineers, • B.S. in Mechanical/Biomedical Engineering or other related degree with 8+ years of experience in biomedical research and/or product development, • M.S. in Mechanical/Biomedical Engineering or other related degree with 6-7 years of experience in biomedical research and/or product development, • Ph.D. in Mechanical/Biomedical Engineering or other related degree with 3-5 years of experience in biomedical research and/or product development, • Higher or lower years of experience will be considered for this role, potentially at a different level in the same job family, • Theoretical and experimental background in structural mechanics and/or biomechanics, • Experience with additive manufacturing and rapid prototyping processes for product design and development, • Experience with 3D modeling using CAD software, Solidworks preferred, • Experience with scripting/programming, • Experience with finite element analysis, • Experience in medical device industry

Job DescriptionDescriptionAlign Technology is the industry leader and innovator in medical devices which focuses on revolutionizing the digital dental and orthodontic industry. Align Technology is looking for an R&D Engineer III, 3D Printing for our San Jose, CA office. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry. The R&D Engineer III, 3D Printing will be responsible for planning, leading, and executing projects focusing on new product design and development. As an R&D Engineer, they will be a key team member to conduct research and development and optimize product design along a highly multidisciplinary team working on 3D printing systems, processes, materials and software. This role will be part of Align Technology’s goal to deliver our clear aligners (Invisalign®) to our customers. Role expectations • Lead product development projects and research projects until product launch., • Leverage 3D technologies, software-platforms, and biomechanical principles to incorporate novel solutions into design for orthodontic devices., • Design and evaluate product prototypes with biomechanical test models and experimentation., • Create testing plans to cover efficacy, reliability, verification, and validation., • Connect product outcomes back to the inputs and outputs of advanced 3D manufacturing processes., • Define procedures to evaluate real-world product performance and conduct bench top testing in accordance with FDA/ISO guidelines., • Collaborate with cross-functional teams to supplement functional performance testing with metrological analysis and/or material characterization., • Coordinate the materials involved in experimental testing in the product development lifecycle., • Organize and investigate root cause analysis on complex data sets., • Utilize statistical tools to formulate, test, and interpret hypotheses., • Communicate project status and present findings to all levels of stakeholders., • Drive internal/external stakeholders’ feedback into the next waves of product development., • B.S, M.S., or Ph.D. in Mechanical/Biomedical Engineering or other related degrees/equivalent work experience., • 5+ years of experience in biomedical research and/or product development., • Experience with additive manufacturing and rapid prototyping processes for product design and development., • Theoretical and experimental background in structural mechanics and/or biomechanics., • Experience with 3D modeling using CAD software, Solidworks preferred., • Experience with scripting/programming., • Experience with finite element analysis., • Experience in medical device industry., • Experience in orthodontics and/or dental industry., • Ability to generate creative solutions and iteratively evaluate concepts, designs, or methods., • Comfort with test method development and documentation best practices in regulated industries., • Experience with metrological tools and outputs, for example, computed tomography, microscopy, etc., • Experience with mechanical or biomechanical equipment and/or material characterization techniques., • Experience with experimental statistical analysis., • Strong problem-solving skills, attention to detail, collaboration skills, and ability to prioritize multiple tasks.

Job DescriptionProcess Development Engineer Status: Full-time, Exempt Reports to: Sr. Director of R&D Location: Onsite Santa Clara, CA About the Role VahatiCor, a T45 Labs portfolio company, is seeking a hands-on Process Development Engineer with strong catheter device experience, deep process development expertise, and a track record of building scalable, compliant manufacturing processes. The engineer will collaborate closely with R&D, Quality, and Manufacturing to establish robust processes, equipment, and documentation in a fast-paced, startup environment. Key Responsibilities · Oversee supplier performance and relationships to guarantee consistent delivery of high-quality components, materials, and finished goods. · Develop and qualify test procedures to assess critical quality attributes and product specifications. · Design and implement fixtures and methodologies for product testing and manufacturing processes. · Author and execute comprehensive engineering protocols and reports to support phases of Design Verification and Process Validation. · Author and maintain process documentation (MPIs, SOPs, work instructions, test methods, protocols, and validation reports). · Partner with R&D and Quality to ensure all processes meet FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements. · Lead transfer of catheter manufacturing processes from external contract manufacturers to internal operations. · Plan and execute process characterization, DOE, and capability studies to ensure consistency and scalability. · Develop, optimize, and validate manufacturing processes, including equipment, tooling, and fixtures. · Perform/support root cause analysis and corrective actions (CAPA) to address manufacturing issues and supplier corrective actions (SCARs) to address issues at the supplier. Qualifications · Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline. · 3-5 years of hands-on process development experience in the regulated medical device industry (catheter or interventional device strongly preferred). · Demonstrated success in process transfer, scale-up, and validation. · Experience with catheter assembly, bonding, molding, extrusion, and testing methods. · Strong knowledge of FDA QSR, ISO 13485, and risk management standards. · Proficiency in equipment qualification (IQ/OQ/PQ), DOE, and statistical analysis tools. · Strong documentation and communication skills; able to thrive in a dynamic startup environment. · Hands-on, proactive problem-solver with startup mentality. Eligibility Candidates must be legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas. Location & Compensation This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package. The anticipated salary range of this position is $115,000 - $155,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. Equal Employment Opportunity Statement T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. Third-Party Recruiter Notice We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email .

Job Description About Ceribell Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement! Position Description Ceribell is looking for a Senior Firmware Engineer / Senior Embedded Engineer who is passionate about biomedical applications and who has experience in the development of embedded or IoT products. The successful candidate will join the R&D team and will play a key role in the development of the next generation of Ceribell's life saving technologies. Our firmware development stack is based around a STMicroelectronics STM32 ARM Cortex microcontroller and we use FreeRTOS, the IAR Embedded Workbench, and the TouchGFX framework. You must be able to work collaboratively as part of a cross-functional R&D team, but you must also be able to take individual ownership for development, testing, and documentation of your projects. What you'll achieve • Develop and test firmware features for Ceribell's EEG systems, • Understand user needs and translate them to the development of new and improved features, • Contribute to GUI development using frameworks such as Qt, TouchGFX, LVGL, or custom OpenGL-based stacks, • Participate in code reviews, peer reviews, and risk management activities, • Create and revise technical documentation, • Provide input on firmware and hardware architecture for new and existing productsWhat you'll need to be successful, • Bachelor's Degree in electrical engineering, computer science, biomedical engineering or, • related field. Graduate degree preferred, • 5+ years of experience in firmware development of a commercial product, • Proficient in C/C++ and experienced with firmware development on ARM based systems, • Hands-on experience developing GUIs for embedded devices using Qt, TouchGFX, LVGL, or other embedded graphics frameworks, • Direct experience with development of WiFi connected / IoT devices preferred, • Strong analytical skills, detail-oriented and collaborative In addition to your base compensation, Ceribell offers the following: • Annual Bonus + Equity Opportunity, • 100% Employer paid Health Benefits for Employees, • 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection), • 100% paid Life and Long-Term Disability Insurance, • 401(k) with a generous company match, • Employee Stock Purchase Plan (ESPP) with a discount, • Monthly cell phone stipend, • Flexible paid time off, • 11 Paid Holidays + 5 Company Wellness Days, • Excellent parental leave policy, • Fantastic culture with tremendous career advancement opportunities, • Joining a mission-minded organization!Compensation Range$130,000—$165,000 USD

Job Description The Role We are seeking a talented and collaborative Computer Vision/Deep Learning Engineer to join our multi-disciplinary team. In this role, you'll work closely with hardware/software engineers and medical experts to transform raw sensor data into life-saving physiological insights. Your contributions will be integral to the team's success. You will help design and build the computer vision and signal processing pipelines that extract critical information from video, depth, and radar data streams. This is a hands-on role where your expertise will directly influence the development of our core technologies. Key Responsibilities • Collaborate with the team to analyze complex, multi-modal sensor data to identify and isolate physiological signatures and human motion patterns., • Design, develop, and implement robust deep learning models for human pose estimation and tracking in Python., • Work in close partnership with hardware/software engineers to define requirements, develop solutions, and integrate them into our broader systems., • Rigorously test and validate algorithm performance, ensuring accuracy and reliability., • Deep expertise in deep learning for computer vision, specifically in human pose estimation and tracking., • A solid understanding of signal processing theory and practice, including filtering, spectral analysis (FFT), and feature extraction., • Proficiency in Python and its scientific computing stack (e.g., NumPy, SciPy, Pandas, scikit-learn, Matplotlib)., • Demonstrated experience with a modern deep learning framework such as PyTorch or TensorFlow., • Excellent communication skills and a proven ability to work effectively in a collaborative, fast-paced R&D environment., • Prior experience with body-part segmentation, keypoint detection, and 3D pose reconstruction., • Strong foundational knowledge of radar systems, including FMCW/CW principles and range-Doppler processing., • Proficiency in C++ for performance-critical applications or algorithm deployment., • Prior project experience in biomedical engineering, physiology, or medical device development., • Familiarity with database querying using SQL.Company DescriptionAt Autonomous Healthcare, we are at the forefront of medical innovation, developing the next generation of devices that will revolutionize patient care. Our mission is to commercialize breakthrough medical technologies by leveraging cutting-edge AI and autonomous systems. We believe that the best solutions are built together, and we are looking for a key member to join our collaborative R&D team.At Autonomous Healthcare, we are at the forefront of medical innovation, developing the next generation of devices that will revolutionize patient care. Our mission is to commercialize breakthrough medical technologies by leveraging cutting-edge AI and autonomous systems. We believe that the best solutions are built together, and we are looking for a key member to join our collaborative R&D team.

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Field Service Engineer II - Semiconductor. PVD or semiconductor vacuum equipment with AS degree is required, Bachelors degree in engineering is preferred.

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