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Quality Engineer – Software Validation & Supplier Management We are seeking a skilled Quality Engineer with expertise in non-product software validation, supplier management, and SaMD quality support. This role will play a key part in ensuring compliance with FDA, ISO, and international regulatory standards while supporting continuous improvement of our Quality Management System (QMS). Responsibilities • Develop and execute validation strategies for software tools and infrastructure using FDA’s Computer Software Assurance (CSA) approach., • Draft, execute, and maintain validation protocols, risk assessments, and reports., • Ensure validation documentation aligns with FDA and ISO 13485 expectations., • Plan and perform supplier evaluations, audits, and risk assessments., • Maintain supplier quality agreements and monitor ongoing compliance., • Support supplier onboarding and continuous performance monitoring., • Contribute to SaMD design control documentation, including risk management, requirements traceability, and verification/validation., • Support preparation of documentation for FDA pre-market submissions., • Drive continuous improvement initiatives aligned with ISO 13485, IEC 62304, and FDA QSR., • Lead CAPA investigations, internal audits, and process improvements., • Provide training and guidance to cross-functional teams on quality best practices. Qualifications • Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or related field., • Proven experience in quality assurance or quality engineering within the medical device or SaMD industry., • Strong knowledge of FDA CSA guidance, ISO 13485, and 21 CFR Part 11/820 requirements., • Experience with supplier qualification and management., • Familiarity with SaMD design control (IEC 62304) and risk management (ISO 14971)., • Hands-on experience with eQMS platforms and software validation in cloud environments., • Excellent documentation skills and high attention to detail., • Strong communication and cross-functional collaboration abilities.

Job Description Join Our Team as a Quality Inspection Engineer! Are you passionate about ensuring products meet the highest standards of quality and precision? As a Quality Inspection Engineer, you will ensure that the Quality Inspection team performs dimensional, functional, and visual inspections of provided assemblies and products to specifications. This person must be technically competent and should be able and willing to take active participation in the day-to-day workload of the team as business needs require. In addition, this role will be a customer-facing role, with frequent customer and occasional regulatory interaction. This role is based out of our location in Austin, Texas. Please note that this role is for Maestro Logistics, which is a sister company to OsteoCentric Technologies. To learn more about Maestro, please visit our site. In this role you will: • Create and revise standard operating procedures (SOPs) and work instructions., • Develop, validate, and document test methods., • Conduct training of quality inspectors., • Assure all quality inspection operations are performed in accordance with procedures, • Provide technical support to quality inspections team, • Track recurring issues and escalate as needed to achieve root cause and corrective action, • Interface daily with customers to provide status of open issues and drive those items to closure., • Handle materials in accordance with procedures and maintain traceability of component materials as to inspection status, • Interface with cross-functional team to drive improvements in inspections area., • Update Quality Inspection procedures and Inspection plans as needed., • Investigate customer complaints and SCARs, • Bachelor’s degree in engineering or similar field, • 1-2+ years of experience in manufacturing quality control/inspection, • Experience with reading and understanding drawings, blueprints, piece prints, and G&DT, • Experience with software development and validation, • Experience in Medical Device Quality or similar regulated field About Us: Maestro Logistics is an ISO 13485:2016 certified, third-party service provider for small to mid-sized medical device companies. We offer a variety of a la carte services including critical quality inspection, manufacturing, and customized fulfillment services. Our facility in Austin, Texas is equipped to receive, clean, and redistribute devices returned from the field. Benefits: • Significant employer contributions to Health, Vision, and Dental plans, • A fully employer-sponsored life insurance plan, • Voluntary: Additional Life/AD&D Insurance, Long Term Disability, Short-Term Disability, Accident Insurance, Hospital Indemnity Coverage, and Critical Illness Insurance, • 401(k) Plan, • 15 Days of Paid Time Off (PTO), • 10 Holidays + 2 Floating Holidays of your choice, • Office provided snacks!

Job Description Location and Travel: This is a remote position; however, preference will be given to candidates located in Austin, TX, Phoenix, AZ, Atlanta, GA, Reno, NV, Grand Rapids, MI, or Las Vegas, NV. This position may require travel to all of the above listed locations. Company Description: Meade Engineering is a full-service design firm specializing in innovative and cost-effective engineering solutions for data centers, cloud providers, and large-scale construction projects. Our team of expert engineers, designers, and consultants is dedicated to delivering high-quality, reliable, and sustainable solutions that drive the industry forward. At Meade Engineering, we foster a collaborative and dynamic work environment where creativity, technical excellence, and professional growth are at the forefront. We take pride in our commitment to innovation, efficiency, and superior service-values that not only define our projects but also shape our workplace culture. If you're looking to be part of a company that values expertise, teamwork, and cutting-edge design, we'd love to hear from you! Job Description: MEI has a job opportunity for an experienced Professional Electrical Engineer to be an integral member of our design team. The scope of projects will include data centers, industrial buildings, offices and other high-profile construction projects. This role will be highly collaborative amongst MEI staff, clients, vendors, and external disciplines. Travel to job sites may be required for site observations and client meetings. Job Duties: • Responsible for designing electrical systems and performing design calculations., • Review, signing and sealing of projects., • Review submittals, RFIs, change orders, preparation of record drawings, site visits, inspections and participation in commissioning work., • Writing and editing of electrical equipment specifications, selecting equipment, electrical systems and devices., • 5-10+ years of Professional Electrical Engineering design experience in the construction industry., • Must hold a valid Electrical P.E. license and Bachelor's degree in Electrical Engineering (will consider Engineering in Training certification)., • Experience designing power systems for data centers, commercial offices, manufacturing facilities, medical buildings, or other large commercial projects., • Experience working independently, managing priorities and providing mentorship to junior staff., • Strong understanding of National and International Building Codes and NFPA Standards., • Advanced knowledge of equipment power requirements, including large scale standby and emergency power system, including interactive generator controls systems., • Experienced in producing Protective Device Coordination and Arc Flash studies is preferred., • Experienced with Medium Voltage equipment selection and specifications is preferred., • Ability to think strategically and demonstrate flexibility in order to achieve long-range objectives., • Self-motivated, comfortable with ambiguity and motivated to work as a team., • Top-notch organization, attention to detail combined with excellent written and oral communication skills. All full-time employees receive a comprehensive benefit package that includes, but is not limited to, medical, dental, and vision insurance with 100% of medical premiums covered by the employer, short and long-term disability insurance, life insurance, a 401(k), vacation time, paid holidays off, and yearly performance-based bonus eligibility. MEI is an Equal Employment Opportunity employer. We do not discriminate based on race, color, religion, sex, national origin, age, disability, genetic information, sexual orientation, gender identity, veteran status, or any other protected characteristic under applicable laws. We believe in equal employment opportunities for all and encourage individuals from all backgrounds to apply. Job Posted by ApplicantPro

Job Description Location: Austin, TX Employment Type: Full-time, In-Office Department: Engineering Salary: Total compensation around $300,000. Salary of $220,000 - $250,000 annually plus equity. We're hiring a Front-End Senior Software Engineer with experience building web applications and service oriented architecture to help us build the core of our stack. This is a full-time, in-office position based in Austin, TX. As a Front-End Sr Software Engineer you will: * Build an experience for people to buy insurance that is so simple and intuitive your least-tech savvy relative could use it without help, regardless of device or platform. * Create a way for customers to document damage, making the claims process smarter and easier–no matter how they access our services. * Design rating engines for calculating how much an insurance policy should cost * Combine property intelligence APIs sources to flag flood, fire, and vandalism risks What You'll Bring: * Experienced: This isn't your first rodeo. There's no specific minimum number of years requirement, but we expect you to be able to dive into a complex codebase without too much spin-up. Past experience as a team lead is definitely a plus. * Builder: You like the product-side of engineering and have thoughtful opinions on what the user experience should be. You're not the type of engineer who wants a fully-fleshed out spec thrown over the wall for you to code. * Pragmatic: We prioritize impact and delivery. You balance speed and quality, making thoughtful trade-offs to solve problems effectively. You leverage off-the-shelf solutions so we don’t re-invent the wheel but understand when a custom solution is appropriate. You'll be deploying code to production within hours of starting and working with us to iteratively build solutions. * Specific languages: We don't really care if you've worked in our stack before as long as you're happy to learn it. If you're sharp enough to be on this team, you're sharp enough to learn any language or framework quickly. Our Stack and Tools: * Python 3 / Kotlin * Typescript * React (Next.js) * Django / FastAPI * Postgres * Kafka (we build on an event driven architecture) * AWS (EKS) * Github Actions with a full CI/CD Pipeline Compensation and Benefits: * Total compensation around $300,000 * Salary of $220,000 - $250,000 annually * Equity in the company * 3 weeks PTO plus six federal holidays * Health insurance including Medical, Dental, Vision, Life, Disability, HSA, FSA * 401K * Free snacks & regular team lunches Location: * Austin, TX Steadily is building a workplace environment of team members who are passionate and excited to be together in person. Our office is in central Austin, and is key to our fast-paced growth trajectory. Why Join Steadily * Good company. Our founders have three successful startups under their belt and have recruited a stellar team to match. * Top compensation. We pay at the top of the Austin, TX market (see comp). * Growth opportunity: We’re an early-stage, fast-growing company where you’ll wear a lot of hats and shape product decisions. * Strong backing. We’re growing fast, we manage over $20 billion in risk, and we’re exceptionally well-funded. * Culture: Steadily boasts a very unique culture that our teammates love. We call it like we see it and we’re nothing if not candid. Plus, we love to have a good time. Check out our culture deck to learn what we’re all about. * Awards: We’ve been recognized both locally and nationally as a top place to work. We were named a Top 2025 Startup in Newsweek, winner of Austin Business Journal’s Best Places to Work in 2025, recognized in Investopedia’s Best Landlord Insurance Companies, ranked No. 6 on Inc’s list of Fastest Growing Regional Companies, 44th on Forbes’ 2025 Best Startup Employers list, and 63rd on the prestigious Inc 5000 Fastest Growing Companies list. We’re excited to meet you!

Job Description Location: Austin, TX Employment Type: Full-time, In-Office Department: Engineering Salary: Total compensation around $400,000. Salary of $220,000 - $250,000 annually plus equity. We're hiring a Staff Software Engineer with experience building web applications and service oriented architecture to help us build the core of our stack. This is a full-time, in-office position based in Austin, TX. As a Staff Software Engineer you will: * Build an experience for people to buy insurance that is so simple and intuitive your least-tech savvy relative could use it without help, regardless of device or platform. * Create a way for customers to document damage, making the claims process smarter and easier–no matter how they access our services. * Design rating engines for calculating how much an insurance policy should cost * Combine property intelligence APIs sources to flag flood, fire, and vandalism risks What we're looking for: * Experienced: This isn't your first rodeo. There's no specific minimum number of years requirement, but we expect you to be able to dive into a complex codebase without too much spin-up. Past experience as a team lead is definitely a plus. * Builder: You like the product-side of engineering and have thoughtful opinions on what the user experience should be. You're not the type of engineer who wants a fully-fleshed out spec thrown over the wall for you to code. * Pragmatic: We prioritize impact and delivery. You balance speed and quality, making thoughtful trade-offs to solve problems effectively. You leverage off-the-shelf solutions so we don’t re-invent the wheel but understand when a custom solution is appropriate. You'll be deploying code to production within hours of starting and working with us to iteratively build solutions. * Specific languages: We don't really care if you've worked in our stack before as long as you're happy to learn it. If you're sharp enough to be on this team, you're sharp enough to learn any language or framework quickly. Our Stack and Tools: * Python 3 / Kotlin * Typescript * React (Next.js) * Django / FastAPI * Postgres * Kafka (we build on an event driven architecture) * AWS (EKS) * Github Actions with a full CI/CD Pipeline Compensation and Benefits: * Total compensation around $400,000 * Salary of $220,000 - $250,000 annually * Equity in the company * 3 weeks PTO plus six federal holidays * Health insurance including Medical, Dental, Vision, Life, Disability, HSA, FSA * 401K * Free snacks & regular team lunches Location: * Austin, TX Steadily is building a workplace environment of team members who are passionate and excited to be together in person. Our office is in central Austin, and is key to our fast-paced growth trajectory. Why Join Steadily * Good company. Our founders have three successful startups under their belt and have recruited a stellar team to match. * Top compensation. We pay at the top of the Kansas City market (see comp). * Growth opportunity: We’re an early-stage, fast-growing company where you’ll wear a lot of hats and shape product decisions. * Strong backing. We’re growing fast, we manage over $20 billion in risk, and we’re exceptionally well-funded. * Culture: Steadily boasts a very unique culture that our teammates love. We call it like we see it and we’re nothing if not candid. Plus, we love to have a good time. Check out our culture deck to learn what we’re all about. * Awards: We’ve been recognized both locally and nationally as a top place to work. We were named a Top 2025 Startup in Newsweek, winner of Austin Business Journal’s Best Places to Work in 2025, recognized in Investopedia’s Best Landlord Insurance Companies, ranked No. 6 on Inc’s list of Fastest Growing Regional Companies, 44th on Forbes’ 2025 Best Startup Employers list, and 63rd on the prestigious Inc 5000 Fastest Growing Companies list. We’re excited to meet you!

Job Description About Us Senseye is a NeuroTechnology Company in Austin, TX on the cusp of revolutionizing Mental Health. Over the past 6 years we have invested millions of dollars in R&D to build our platform allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases we are now focused on building the world's first Objective Mental Health Diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed soon by additional indications for Anxiety and Depression. As the world struggles with a mental health crisis, it is not hyperbolic to suggest that an objective diagnostic platform, that gives clinicians a safe and objective accurate approach to identifying and monitoring mental health disease, will redefine how mental health services are provided and will enable access to treatment for hundreds of millions of sufferers. The Senseye platform has the potential to be the technology that drives this change. Role Description We are seeking a Product Quality Engineer with strong experience in software and medical device quality systems to join our team. This individual will play a critical role in ensuring that our SaMD products meet regulatory, quality, and customer requirements throughout the product lifecycle—from development through post-market surveillance. Responsibilities • Partner with Engineering, R&D, Regulatory, and Clinical teams to ensure compliance with ISO 13485, 21 CFR Part 820, IEC 62304, and other applicable standards., • Support design and development activities by developing and reviewing documentation, ensuring design control compliance, and participating in design reviews., • Perform risk management activities per ISO 14971, including creation and maintenance of risk analyses., • Collaborate with development teams on cybersecurity requirements, threat modeling, vulnerability assessments, and post-market monitoring in accordance with FDA, ISO/IEC 27001, and other international standards to ensure product security., • Define and implement non-product software validation strategies in alignment with FDA’s CSA guidance, 21 CFR Part 11 and GAMP 5 principles., • Contribute to the development and continuous improvement of the QMS, with a focus on software-specific quality processes., • Investigate and resolve product quality issues, nonconformances, and CAPAs using root cause analysis techniques., • Lead or support internal and external audits (e.g., FDA, Notified Bodies, ISO registrars)., • Participate in supplier qualification and software supplier evaluation processes., • Monitor post-market product performance and contribute to complaint handling and field actions when needed., • Drive quality metrics reporting and trend analysis to support management reviews and continuous improvement initiatives., • Position requires access to Covered Defense Information for which the US Government requires US Citizenship, • You'll also need to pass an FBI background check, • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline., • 4+ years of experience in medical device quality engineering with 2+years in the SaMD environment (SaMD experience is a must!), • Strong understanding of quality systems and regulatory frameworks, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820/11., • Experience with design control, risk management, and software validation., • Familiarity with Jira, Confluence, and modern QMS or eQMS tools., • Excellent communication, collaboration, and problem-solving skills. Extra Points: • Perform agile software development/quality practices, • Perform Usability and Human Factor Engineering activities for medical devices, • Establish information security against HIPAA, GDPR requirements The compensation for this role is $97,000 - $121,000 annually. Benefits • The freedom and trust to define your role as we design, build, and ship our products, • Competitive salary and stock option plan, • Flexible paid time off (vacation, sick leave, and public holidays), • Flexible schedules, • Company health care plan, • Medical, dental, and vision insurance, • Short and long term disability insurance, • Life insurance policy, • 401k, • Commuter benefits for parking, public transit, carshares, etc., • Mothers' room, • Fully stocked kitchen, • Opportunities for continuing education Senseye is dedicated to building a community of employees that are diverse, passionate, and engaged. We are committed to equal opportunity regardless of race, color, ancestry, religion, gender, gender identity, parental or pregnancy status, national origin, sexual orientation, age, marital status, disability, or veteran status. When we're safe, healthy, and balanced we can accomplish phenomenal things together.

Job DescriptionJob Overview: We are seeking a highly skilled and hands-on Camera Systems Engineer to lead the design and integration of advanced imaging systems. This role requires deep expertise in optics, sensor and lens selection, machine vision, and camera-computer integration. You will play a critical role in developing vision systems that support real-time AI-driven applications in complex environments.Responsibilities • Camera System Design: Define imaging architectures, including sensor, lens, filter, and optical path selection tailored to mission requirements, • Sensor and Lens Evaluation: Select sensors (CMOS, SWIR, MWIR, LWIR, etc.) and lenses based on imaging and environmental performance needs, • Infrared Imaging Expertise: Apply knowledge of infrared imaging (SWIR, MWIR, LWIR) and associated optical components, coatings, test equipment, and calibration techniques, • AI + Vision Integration: Interface with computer vision and AI teams to ensure imaging hardware enables accurate perception and inference, • Prototype Development: Assemble and characterize prototype imaging systems, and define test methods for image quality metrics (MTF, SNR, color accuracy, etc.), • System Interfaces: Implement and troubleshoot camera data pipelines over MIPI CSI-2, USB 3.0, GigE Vision, Ethernet/IP, and Camera Link, • Vendor Engagement: Source and evaluate components from optical and sensor vendors; manage supplier interactions for system integration, • Cross-Functional Collaboration: Partner with software, firmware, and mechanical teams to validate systems across performance and environmental conditionsQualifications, • Bachelor’s or Master’s degree in Optical Engineering, Electrical Engineering, Physics, or a related field, • 5+ years of experience developing camera hardware systems for machine vision or real-time embedded imaging, • Expertise in imaging sensor technologies and optical principles across visible and IR bands, • Deep understanding of infrared imaging systems, including physical componentry, sensor operation, and radiometric performance, • Experience with image calibration and environmental test procedures, • Experience with optical alignment, integration, and test (AI&T) with EO and IR systems, • Proficiency in implementing and debugging common camera software communication protocols (e.g., MIPI CSI-2, USB, GigE Vision, Camera Link), • Strong software skills in Rust and C/C++ for camera control, data acquisition, and system integration, • Familiarity with standard computer vision workflows and tools (e.g., OpenCV), • Strong proficiency in Linux, including experience with kernel drivers, device trees, and camera subsystem integration, • Familiarity with embedded systems, ISP tuning, FPGA-based pipelines, or real-time processing, • Operational experience with collimators, parabolic mirrors, black bodies, and thermal chambers is preferred, • Opto-mechanical design experience is preferred, • Proficiency with optical design and modeling tools (e.g., Zemax, Code V, FRED) is preferred, • Experience working with ruggedized or mobile optical systems (e.g., UAVs, vehicles, field-deployable platforms) is preferred, • Experience in color science, image compression, or multispectral imaging workflows is preferred Benefits, • Medical Insurance: Comprehensive health insurance plans covering a range of services, • Dental and Vision Insurance: Coverage for routine dental check-ups, orthodontics, and vision care, • Saronic pays 100% of the premium for employees and 80% for dependents, • Time Off: Generous PTO and Holidays, • Parental Leave: Paid maternity and paternity leave to support new parents, • Competitive Salary: Industry-standard salaries with opportunities for performance-based bonuses, • Retirement Plan: 401(k) plan, • Stock Options: Equity options to give employees a stake in the company’s success, • Life and Disability Insurance: Basic life insurance and short- and long-term disability coverage, • Additional Perks: Free lunch benefit and unlimited free drinks and snacks in the office Physical Demands, • Prolonged periods of sitting at a desk and working on a computer, • Occasional standing and walking within the office, • Manual dexterity to operate a computer keyboard, mouse, and other office equipment, • Visual acuity to read screens, documents, and reports, • Occasional reaching, bending, or stooping to access file drawers, cabinets, or office supplies, • Lifting and carrying items up to 20 pounds occasionally (e.g., office supplies, packages)This role requires access to export-controlled information or items that require “U.S. Person” status. As defined by U.S. law, individuals who are any one of the following are considered to be a “U.S. Person”: (1) U.S. citizens, (2) legal permanent residents (a.k.a. green card holders), and (3) certain protected classes of asylees and refugees, as defined in 8 U.S.C. 1324b(a)(3).

Job Description Software Engineer About Paradromics Paradromics is building an advanced brain computer interface (BCI) platform engineering neurotechnology solutions for unmet medical needs. A revolutionary leap beyond today’s research-grade BCI, our Connexus® BCI collects neural signals at an industry-leading, high-data rate and is designed for long-term therapeutic use. With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable depression and pain management—allowing millions of people to live happier, healthier, and more enriching lives. The Role As a Software Engineer at Paradromics, you’ll work closely with our team of Scientists and Engineers to develop software that enables our clinical applications. You will help design software to restore communication ability for our BCI users, enabling successful clinical studies of the Connexus System. Responsibilities • Design and develop software that enables clinical studies and BCI user applications, • Develop tools and processes to accelerate the translation of cutting edge science to real-world application, • Support BCI data analysis at scale, • Interact closely with cross-functional teams spanning hardware, neuroscience, and quality teams to design and implement software prototypes, algorithms, and systems that drive towards product development, • Bachelor's degree in Computer Science or a related technical field; or equivalent real world experience, • Highly proficient in Python and experience with C++, Rust, or Go, • Has experience developing Linux and/or MacOS applications, • Working knowledge of operating systems concepts, • Experience implementing performant numerically-focused algorithms, • Experience with machine learning techniques and tools, • Experience collaborating with scientists and engineers Powered by JazzHR hQIogsvwhA

Job Description Location: Austin, TX Employment Type: Full-time, In-Office Department: Engineering Salary: Total compensation around $300,000. Salary of $220,000 - $250,000 annually plus equity We're hiring a Senior Software Engineer with experience building web applications and service oriented architecture to help us build the core of our stack. This is a full-time, in-office position based in Austin, TX. As a Sr Software Engineer you will: * Build an experience for people to buy insurance that is so simple and intuitive your least-tech savvy relative could use it without help, regardless of device or platform. * Create a way for customers to document damage, making the claims process smarter and easier–no matter how they access our services. * Design rating engines for calculating how much an insurance policy should cost * Combine property intelligence APIs sources to flag flood, fire, and vandalism risks What You'll Bring: * Experienced: This isn't your first rodeo. There's no specific minimum number of years requirement, but we expect you to be able to dive into a complex codebase without too much spin-up. Past experience as a team lead is definitely a plus. * Builder: You like the product-side of engineering and have thoughtful opinions on what the user experience should be. You're not the type of engineer who wants a fully-fleshed out spec thrown over the wall for you to code. * Pragmatic: We prioritize impact and delivery. You balance speed and quality, making thoughtful trade-offs to solve problems effectively. You leverage off-the-shelf solutions so we don’t re-invent the wheel but understand when a custom solution is appropriate. You'll be deploying code to production within hours of starting and working with us to iteratively build solutions. * Specific languages: We don't really care if you've worked in our stack before as long as you're happy to learn it. If you're sharp enough to be on this team, you're sharp enough to learn any language or framework quickly. Our Stack and Tools: * Python 3 / Kotlin * Typescript * React (Next.js) * Django / FastAPI * Postgres * Kafka (we build on an event driven architecture) * AWS (EKS) * Github Actions with a full CI/CD Pipeline Compensation and Benefits: * Total compensation around $300,000 * Salary of $220,000 - $250,000 annually * Equity in the company * 3 weeks PTO plus six federal holidays * Health insurance including Medical, Dental, Vision, Life, Disability, HSA, FSA * 401K * Free snacks & regular team lunches Location: * Austin, TX Steadily is building a workplace environment of team members who are passionate and excited to be together in person. Our office is in central Austin, and is key to our fast-paced growth trajectory. Why Join Steadily * Good company. Our founders have three successful startups under their belt and have recruited a stellar team to match. * Top compensation. We pay at the top of the Austin, TX market (see comp). * Growth opportunity: We’re an early-stage, fast-growing company where you’ll wear a lot of hats and shape product decisions. * Strong backing. We’re growing fast, we manage over $20 billion in risk, and we’re exceptionally well-funded. * Culture: Steadily boasts a very unique culture that our teammates love. We call it like we see it and we’re nothing if not candid. Plus, we love to have a good time. Check out our culture deck to learn what we’re all about. * Awards: We’ve been recognized both locally and nationally as a top place to work. We were named a Top 2025 Startup in Newsweek, winner of Austin Business Journal’s Best Places to Work in 2025, recognized in Investopedia’s Best Landlord Insurance Companies, ranked No. 6 on Inc’s list of Fastest Growing Regional Companies, 44th on Forbes’ 2025 Best Startup Employers list, and 63rd on the prestigious Inc 5000 Fastest Growing Companies list. We’re excited to meet you!

Job Description IEC 62304 Quality Specialist (Design Assurance Engineer) No C2C. Fulltime permanent role (no sponsorship). Note: non-medical device industry exp application will NOT be considered. Overview We are looking a highly skilled IEC 62304 expert as Software Quality Engineer to work in Austin, TX (Onsite). MUST Have: hands-on experience with • IEC 62304 (Medical Device Software Life Cycle Processes), • ISO 14971 (Risk Management for Medical Devices), • ISO 13485 (Quality Management Systems) Key Responsibilities • Ensure full compliance with global medical device regulations and standards, including: 1. IEC 62304 (Medical Device Software Life Cycle Processes), 2. ISO 14971 (Risk Management for Medical Devices), 3. ISO 13485 (Quality Management Systems), 4. FDA 21 CFR Part 820 (Quality System Regulation), 5. 21 CFR Part 11 (Electronic Records and Signatures), 6. Cybersecurity guidance for medical devices (e.g., FDA premarket guidance, AAMI TIR57/97, etc.) • Review, maintain, and improve Quality System procedures and work instructions governing software development, validation, and lifecycle management for embedded, standalone, and cloud-based medical device software., • Partner closely with cross-functional teams including R&D, Systems Engineering, Regulatory Affairs, Manufacturing, and Clinical teams to ensure that software development activities are fully integrated with design controls and compliant with applicable standards., • Review and approve software design documentation, including: 1. Software Development Plans, 2. Software Requirements Specifications (SRS), 3. Software Architecture and Design Documents, 4. Risk Management documentation (including Software Failure Modes and Effects Analysis), 5. Verification and Validation protocols, test plans, test cases, and reports. • Conduct software quality audits and assessments to ensure compliance with internal processes, SOPs, and applicable regulatory requirements., • Actively participate in software risk management processes, facilitating hazard analyses, failure mode assessments, and risk mitigations throughout the product lifecycle., • Provide oversight and review of process validation protocols for software systems used in manufacturing, testing, installation, service, and support of medical devices., • Support regulatory submissions including 510(k), PMA, CE Technical Files, and international regulatory dossiers, ensuring complete and compliant software documentation., • Participate in usability testing, clinical lab evaluations, cadaveric labs, and design validation activities to ensure software meets intended use and user needs., • Provide expert guidance to teams during internal and external audits (e.g., FDA inspections, Notified Body audits, MDSAP audits)., • Assist in design transfer activities to ensure smooth transition from product development to manufacturing with appropriate validation of test methods, process controls, and inspection methods., • Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or related technical discipline. Master’s degree preferred., • Minimum 5+ years of hands-on experience as a Software Quality Engineer in the medical device industry (Class II and/or Class III devices preferred)., • In-depth knowledge of design controls, risk management, and software lifecycle processes specific to regulated medical devices., • Demonstrated experience with IEC 62304-compliant software development and verification/validation processes., • Strong working knowledge of ISO 14971, ISO 13485, 21 CFR Part 820, and current FDA guidance documents related to software in medical devices., • Prior experience supporting 510(k), PMA, EU MDR, or other international regulatory submissions for medical device software., • Ability to collaborate effectively with cross-functional teams and communicate quality requirements clearly to both technical and non-technical stakeholders., • Excellent written, verbal, and interpersonal communication skills., • Experience with connected medical devices, or software as a medical device (SaMD)., • Familiarity with cybersecurity frameworks applicable to medical device software., • Experience with cloud-based or mobile medical applications., • Direct interaction with FDA, Notified Bodies, or MDSAP auditors during inspections.

Job Description Ready to simulate success? Join our innovative team! Are you a problem-solver who thrives on tackling complex engineering challenges? Do you geek out over the power of simulation tools like Ansys to bring ideas to life? If so, we want you to be part of our cutting-edge team! At OsteoCentric Technologies, we’re redefining what’s possible. As a Simulation Engineer, you’ll have the opportunity to shape the future, working on groundbreaking projects that make a real impact. With access to state-of-the-art tools, a collaborative team of experts, and an environment that values innovation, this is your chance to flex your technical muscles and take your career to the next level. The Simulation Engineer is responsible for performing advanced simulation and analysis using Ansys software (Mechanical, Motion, LS-DYNA, or optiSLang) to support product design and development. They will perform complex simulations, analyze results, and offer optimization recommendations for OsteoCentric products in the Medical Device and Industrial spaces. This role requires a proactive, collaborative engineer with experience in finite element analysis (FEA), dynamic modeling, or optimization processes, capable of working cross-functionally to drive innovation and product quality. This position is required to work in our North Austin office. In this role you will: • Develop, set up, and execute simulation models using Ansys Mechanical, Ansys Motion, Ansys LS-DYNA, or Ansys optiSLang, depending on project requirements., • Perform finite element analysis (FEA) for structural, thermal, and/or dynamic simulations, and provide insights for design improvements., • Collaborate with design, R&D, and product development teams to define simulation requirements and translate them into functional models., • Analyze and interpret simulation results, generating comprehensive reports to inform engineering and design decisions., • Conduct sensitivity and optimization studies using Ansys tools to ensure robustness and reliability in product design., • Troubleshoot and validate models to ensure accuracy and alignment with real-world testing and performance., • Participate in product testing and validation to correlate simulation data with physical data., • Stay current with advances in simulation technology and incorporate new methodologies to enhance simulation capabilities., • Prepare, deliver, and support technical presentations, publications, and IP filings based on the learnings from simulations, for both internal and external audiences., • Function as simulation Subject Matter Expert (SME), including training others on the mechanics and use of simulation tools, administrating and coordinating licenses and subscriptions, and recommending appropriate hardware., • Strong understanding of finite element analysis (FEA) and dynamic modeling principles., • Proficiency in developing, validating, and optimizing complex simulation models., • Familiarity with multi-physics simulation, particularly structural, thermal, and/or dynamic analyses., • Knowledge of scripting languages (e.g., Python) and familiarity with CAD software (e.g. SolidWorks)., • Strong analytical, problem-solving, and decision-making abilities., • Excellent verbal and written communication skills, with the ability to create clear and actionable reports., • Bachelor’s degree in Mechanical Engineering, Aerospace Engineering, or Biomedical Engineering (with Mechanical concentration) from an accredited institution. Graduate degrees and certificates are preferred., • Minimum of 5 years of experience in engineering simulation, specifically with Ansys tools. UnifiMI Industrial was founded in 2024 and is a wholly-owned subsidiary of OsteoCentric Technologies. OsteoCentric was founded in 2015 to design, develop and innovate new advanced medical device technologies. Our flagship UnifiMI technologies have revolutionized the implant to bone interface utilizing both patented minimally invasive bone preparation technology and unique next-generation thread geometries. Our goal is to leverage MIS technology to significantly improve and accelerate a patient’s path to recovery. Our two state-of-the-art global innovation headquarters are located in Austin, Texas and Logan, Utah. Fun facts about us: • 70+ patents globally, • 100,000+ surgical implants used, • Devices in 90+ level one trauma centers, • 20 FDA Clearances and counting, • 11 Commercialized Products Benefits: • Significant employer contributions to Health, Vision, and Dental plans, • A fully employer-sponsored life insurance plan, • Voluntary: Additional Life/AD&D Insurance, Long Term Disability, Short-Term Disability, Accident Insurance, Critical Illness Insurance, and Hospital Indemnity Insurance, • 401(k) Plan, • 15 days of Paid Time Off (PTO), • 10 Holidays + 2 Floating Holidays of your choice, • We do not accept applications from third-party recruiters or staffing agencies., • At this time, we are unable to sponsor work visas. Applicants must have authorization to work in the United States without sponsorship.

We are seeking a Product Quality Engineer with strong experience in software and medical device quality systems to join our team. Contribute to the development and continuous improvement of the QMS, with a focus on software-specific quality processes. Investigate and resolve product quality issues,

Job DescriptionStaff Product Development EngineerAbout ParadromicsBrain-related illness is one of the last great frontiers in medicine, not because the brain is unknowable, but because it has been inaccessible. Paradromics is building a brain-computer interface (BCI) platform that records brain activity at the highest possible resolution: the individual neuron. AI algorithms then decode this massive amount of brain-data, enabling the seamless translation of thought into treatments. Our first clinical application, the Connexus® BCI, will help people who are unable to speak, due to ALS, spinal cord injuries, and stroke, to communicate independently through digital devices. However, the capabilities of our BCI platform go far beyond our first application. With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable mental illness.The RoleWe are seeking a Staff Product Development Engineer to join our Product Development team in Austin, TX. Reporting to the Senior Director of Product Development, this individual will be a key contributor in maturing our Connexus system from early feasibility through clinical readiness and launch. This role combines strong hands-on mechanical engineering expertise with the ability to mentor junior engineers, instill medical device best practices, and ensure designs meet the highest regulatory and quality standards.Responsibilities • Serve as a senior mechanical engineering contributor and provide SolidWorks technical mentorship for junior engineers., • Lead refinement of the Connexus system through design maturity, formal verification/validation (V&V), and into Pivotal and commercial launch., • Consult with and review designs from the advanced R&D team, guiding them to consider regulatory and quality constraints early in the design process., • Establish, implement, and embed medical device best practices across the engineering team., • Ensure all designs, documentation, and processes align with FDA, ISO, and industry standards.Required Education, • Bachelor’s or Master’s degree in Mechanical Engineering or related technical discipline.Required Qualifications, • Minimum 8 years of medical device development experience, preferably in the active implantables space., • Proven experience refining medical devices through V&V and clinical readiness, including DFM, FMEA, TM development, TMV, IQ/OQ/PQ/PPQ., • Strong foundation in medical device best practices, including design controls, ISO 13485, ISO 14971, and DHF management., • Advanced SolidWorks expertise (CAD, assemblies, GD&T)., • Hands-on experience with troubleshooting and maturing early-stage medical device designs., • Demonstrated ability to mentor junior engineers and embed best practices across team workflows.Preferred Qualifications, • Experience with injection molding, laser welding, CNC machining, sheet metal, and cleaning processes., • Prior success scaling engineering processes at small or startup medtech companies., • Exposure to electronics integration for implantables (power, telemetry)., • Experience leading or supporting regulatory submissions. DZfGKx8veA

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