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Job Title Sr. Manufacturing Engineer Location: Plymouth, MN, 55442 Duration : 6 months with Possible Extension No Benefits Provided Seeking a motivated and results-driven Senior Manufacturing Engineer to support New Product Introduction (NPI) and manufacturing operations for medical device products. This role will focus on yield improvement, process optimization, product transfer, and manufacturing scale-up in a fast-paced production environment. Key Responsibilities • Lead yield and productivity improvement projects across manufacturing processes., • Support new product introduction (NPI), pilot builds, and transfer to production., • Troubleshoot manufacturing issues using Root Cause Analysis, DMAIC, and other problem-solving tools., • Analyze manufacturing data to improve quality, efficiency, and throughput., • Coordinate tooling, equipment, and process development activities., • Collaborate with Operations, Quality, R&D, Supply Chain, and Regulatory teams., • Ensure compliance with FDA, ISO 13485, GMP, and quality system requirements., • Mentor junior engineers and support continuous improvement initiatives. Required Qualifications • Bachelor’s degree in Mechanical, Biomedical, Chemical, or related Engineering field from a US institution., • 3–5+ years of experience in medical device manufacturing or process engineering., • Experience with NPI, process development, or manufacturing support., • Strong analytical, troubleshooting, and project management skills., • Ability to provide examples of process improvements, yield improvements, or productivity enhancements implemented., • Strong communication and teamwork skills. Preferred Qualifications • Experience in catheter or medical device manufacturing., • Knowledge of assembly, bonding, soldering, reflow, or packaging processes., • Experience working in FDA and ISO-regulated environments. Additional Details • Location: Plymouth, • Schedule: 8:30 AM – 5:30 PM, • Travel: Up to 25% including international travel.

Job Title : Sr. Manufacturing Engineer Location : Plymouth, MN 55442 Duration : 06 months Job Description: • Manufacturing & Yield Improvement, • Lead yield improvement initiatives across catheter manufacturing processes, including reflow, stringing, assembly, soldering, bonding, and packaging., • Apply structured problem-solving methodologies (e.g., DMAIC, Root Cause Analysis, A3) to resolve manufacturing issues and improve process capability and robustness., • Analyze manufacturing data to identify trends, process variation, and opportunities for cost, quality, and throughput improvements., • Technical Leadership & Execution, • Serve as a technical subject matter expert in catheter manufacturing processes, materials, and equipment., • Coordinate the design, procurement, build, and debugging of tooling, machinery, and test equipment., • Support new product introductions (NPI), process scale up, and technology transfer from R&D to manufacturing., • Work collaboratively with Quality, Process Development, R&D, Supply Chain, Operations, and Regulatory teams to ensure successful launches and sustained performance., • Ensure manufacturing processes comply with FDA, ISO 13485, GMP, and Abbott quality system requirements., • Bachelor’s degree in Mechanical, Chemical, Biomedical, or other relevant engineering discipline, or equivalent technical experience.

Principal R&D Engineer (Structural Heart / Catheter Systems) Location: Minneapolis, MN Overview We are seeking a Principal R&D Engineer to serve as a technical leader in the design and development of advanced catheter-based systems within the structural heart space. This is a high-impact, pre-commercial role where you will help shape a next-generation therapy from concept through clinical readiness and into commercialization. You’ll work at the intersection of engineering, clinical insight, and regulatory strategy—contributing directly to a program that is moving through critical development milestones. If you’re motivated by solving complex engineering challenges and want to play a visible role in bringing innovative medical technology to market, this opportunity offers both technical depth and career-defining impact. What You’ll Do • Lead technical decision-making for catheter system architecture, including materials, tolerances, and early process development, • Design, execute, and analyze verification and validation strategies, including test method development, • Drive product development from concept through clinical readiness and commercialization within a regulated design control environment, • Conduct risk assessments using FMEA, tolerance analysis, and failure investigations, • Lead and contribute to design reviews and cross-functional technical discussions, • Translate clinical and user needs into engineering requirements, designs, and test strategies, • Partner with physicians and external advisors to inform product design and usability, • Collaborate with suppliers and manufacturing partners to ensure design feasibility and performance, • Present technical progress, key decisions, and milestones to senior leadership and stakeholders, • Contribute to continuous improvement of product development and manufacturability processes What You Bring Required • Bachelor’s degree in Engineering (Mechanical or Biomedical preferred); advanced degree a plus, • 10+ years of experience in medical device design and development, including technical leadership responsibilities, • Deep expertise in catheter-based systems, including materials (polymers/metals) and bonding methods, • Experience developing Class III implantable medical devices, • Strong understanding of design controls, risk management, and regulatory requirements, • Proficiency with CAD tools (SolidWorks, Creo, or similar), • Experience with design verification, testing, and documentation supporting regulatory submissions, • Strong analytical skills with tools such as Minitab, JMP, or similar, • Experience with structural heart or transcatheter device development, • Familiarity with manufacturing scale-up and process validation, • Knowledge of catheter manufacturing processes (extrusion, braiding, hypotubes, etc.), • Experience working in early-stage or emerging technology environments, • Background collaborating with contract manufacturers and external partners, • Experience mentoring engineers and contributing to team development Why This Role • Be part of a high-visibility program at a critical stage of development, • Work alongside experienced leaders with a track record of advancing medical technologies to market, • Gain end-to-end product development experience, including clinical and regulatory milestones, • Competitive compensation including base salary, performance incentives, and equity participation, • Comprehensive benefits package including medical, dental, vision, 401(k), and paid time off

Job Description Rhythm Express is seeking a Signal Processing AI Engineer to join our team to develop and implement machine learning algorithms used in cardiac remote monitoring. This position will work alongside and collaborate closely with engineers with expertise in signal processing, embedded systems, cloud, cybersecurity, and regulatory. The ideal candidate will graduate soon or has recently completed a bachelor's or master's degree in electrical engineering, computer engineering, computer science, biomedical engineering, or a related field and enjoys learning and stepping into new challenges. A strong foundation in signal processing, time-frequency analysis, deep learning, and machine learning is highly desirable. Experience or coursework in training models from scratch, fine-tuning pretrained models, data analysis and visualization using Python (NumPy, Pandas, Matplotlib, PyTorch/TensorFlow), data structures, algorithms, object-oriented programming, and Generative AI knowledge lookup tools is a plus. We are a leading provider of remote cardiac monitoring services with offices in Arden Hills, MN, Dallas, TX, and Memphis, TN. We have been named by Inc. Magazine as one of the fastest growing private companies in America for three consecutive years. Our Rhythm Express RX-1 mini is the smallest and most advanced one-piece mobile cardiac telemetry (MCT) device on the market. We offer a collaborative and inclusive work environment where personal initiative, development, and learning are highly valued. We provide excellent benefits including medical, dental, and vision coverage, pet insurance, 401(k), paid time off, and generous stock options. This is an on-site position based at our Arden Hills location. Our office is centrally located with nearby access to I-694, Snelling Ave, and I-35W. This facility includes natural light, high-efficiency filters, and UV sterilization to reduce pathogens in the air to keep employees safe.

Job Description How many companies can say they’ve been in business for over 177 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team! Location/Region: This position is located in Minnesota and also covering Indiana. Travel expected for training in California What’s the role? The Field Support Engineer II, with limited supervision, installs, repairs, upgrades and performs preventative maintenance on specified Carl Zeiss Meditec instrumentation in a designated field service territory. Represents Carl Zeiss Meditec at customer locations and works to achieve a high level of customer satisfaction. Responsible for all company issued property (inventory, tools, diagnostic equipment, vehicle, etc.) in accordance with company policies. Maintains a high level of professional communication with their team, customers, management, Sales and Technical Support. Sound Interesting? Here’s what you’ll do: • Diagnose and repair all designated products within an assigned service territory, including preventative maintenance, installations and upgrades per specific training, manuals and Carl Zeiss Meditec guidelines., • Schedule, create, verify and/or modify customer visits as appropriate, by assessing customers’ needs, which may include financial impact to the practice, and patients’ well being., • Complete and submit a field service report on a daily basis according to written procedures as documented in the Field Service reference database., • Complete and submit a weekly expense report according to Carl Zeiss Meditec policies and procedures., • Maintain spare parts inventory according to company guidelines and return specific spare parts as designated by policy., • Support revenue growth through the promotion and retention of service agreements., • Interface with customers in a professional, pleasant and calm demeanor., • Other duties may include, but are not limited to, instructing customers on operation and maintenance of equipment., • Maintains company-issued test equipment and support tools, including spare parts., • 0 – 3 years of previous field service experience required., • BS in Electronics, Engineering, or Computer Technology and related fields preferred., • A+ and Net+ certification preferred., • Theoretical understanding of basic electromechanical, electronic, and optical systems., • Basic understanding of troubleshooting techniques and approaches., • Must have good verbal and written communication skills., • Must have strong computer skills with the ability to obtain specific certifications as required., • Must be able to pass required training to service fine mechanics and optics. Ability to effectively service the equipment on which training is completed. Working Conditions and Special Demands: • Extensive overnight travel is required by automobile and air., • Must be able to travel in the US and internationally for training, meetings, exhibit support and coverage outside assigned territory. The FSE must be able to obtain sufficient credit to cover incurred business expenses which will be reimbursed upon expense report submission and approval., • The position requires an average of four (4) hours driving for service calls, per day. Must have a valid driver’s license and good driving record., • On occasion, must be able to lift up to 50 pounds. Thirty percent of the average workday is spent standing or walking. We have amazing benefits to support you as an employee at ZEISS! • Medical, • Vision, • Dental, • 401k Matching, • Employee Assistance Programs, • Vacation and sick pay, • The list goes on!

Job Description What You’ll Do: The Design Assurance Engineer is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II reusable surgical instruments and disposable medical devices and supports the implementation and management of the digital requirements management system. This position reports to the Director of R&D Engineering. 40% Lead Design Assurance For Representation & Compliance • Represent product quality and compliance in new product development and sustaining engineering projects., • Ensure design and process controls meet regulatory and customer requirements., • Implement medical device requirements management software (Jama) to organize and effectively manage the company’s design and development files., • Create and update controlled documents (QSPs, specifications, methods) within the Quality Management System. 30% Product Testing • Develop and execute implementation, inspection, and test plans for design transfer., • Support R&D with verification/validation protocols, specifications, and reliability testing., • Coordinate external validation activities (e.g., mechanical, functional, biocompatibility, sterilization). 20% Risk Management & Reviews • Lead risk management activities (FMEA, hazard analysis, FTA, statistical analysis)., • Participate in design reviews and change control processes. 20% Technical Guidance & Design Principles • Provide technical guidance on product quality attributes., • Apply Design-to-Cost and Design-for-Manufacturability principles. The Experience, Skills and Abilities Required: • Bachelor of Science in Mechanical Engineering or Biomedical Engineering, • Minimum of 3+ years design assurance or product development., • Understanding of ISO 13485 and FDA 21 CFR 820 compliance., • Experience with full design lifecycle and phase-gate processes., • Understanding of FMEAs, DOEs and Risk Assessment methods, • Strong written and verbal skills for documentation, presentations, and team alignment., • Problem-Solving & Critical Thinking: Analytical skills to identify gaps, assess risks, and draw conclusions., • High degree of accuracy in documentation and reviews., • Working effectively in cross-functional teams (design, manufacturing, regulatory). Preferred Experience, Skills and Abilities: • Experience in medical devices, • Jama Connect requirements management software, • Minitab statistical analysis software, • Knowledge of quality methodologies (Six Sigma, DFSS, DMAIC)., • Project Management, time management, prioritization, and execution., • Leadership, mentoring, and fostering a quality culture. This position is based out of our corporate office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday. Compensation We are committed to equitable and transparent pay practices. The salary range for this position is $72,100 - $115,300, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications. Comprehensive Benefits Offerings • Medical, Dental, and Vision Insurance, • Group Life Insurance, • Short-Term Disability Insurance, • Long-Term Disability Insurance, • 401(k) Plan with Company Match, • Workers' Compensation, • Employee Assistance Program (EAP), • Regular Part-Time Benefit Eligibility, • Training and Development Program, • Tuition Assistance Program, • Paid Time Off, including:, • Holidays, • Floating Holidays, • Vacation, • Earned Sick and Safe Time (ESST)

Job Description Compensation will be made up of a competitive base salary as well as bonus potential determined by your own individual performance and the performance of the organization overall. About This Role The job involves participation in a wide variety of incident investigations, including accident reconstruction. Projects require fieldwork, investigation, analysis, report development, and legal testimony at deposition, trial, or other legal venues. The candidate will provide biomechanics expertise as part of a multi-disciplinary team evaluating accidents of various types and specifically addressing injury causation. The candidate will be responsible for planning, directing, and coordinating activities of small to large-scale client projects to ensure that goals and objectives are accomplished within prescribed timing and financial constraints by performing duties personally or in conjunction with other consultants. Key Responsibilities: • Performs human-injury analysis of vehicular accidents in all transportation modes, including accident reconstruction, injury modeling, and the evaluation of mechanical failures., • Evaluates injury mechanisms in industrial and recreational accidents, including those resulting from mechanical failures, falls, and falling objects., • Project duties will include recruitment, staffing, logistics, and work plan development, as well as technical analysis based on scientific principles., • Interfaces directly with clients, assessing client needs, establishing performance timelines, developing budgets, and explaining complex technical concepts in lay terms., • Identifies and reviews existing media (e.g., photographs, video, witness statements, depositions, police and autopsy reports, medical records, etc.) to develop preliminary conclusions and plan further investigation., • Conducts inspections of accident scenes and of involved or exemplar vehicles, safety equipment, consumer products, and other items as needed., • Supervises original research to obtain and analyze relevant technical data., • Locates and assesses pertinence of scientific literature, existing test data, and governmental regulations., • Designs and conducts testing and/or develops models to obtain and evaluate impact dynamics data., • Conducts analyses of human motion and anthropometry., • Assists in all phases of project management from proposal through closing., • Prepares written reports of findings and conclusions in clear, concise, easy-to-understand terms., • Provides legal testimony in a variety of venues, including courtroom settings., • Performs other duties as assigned., • Bachelor's degree in Mechanical or Biomedical Engineering required, • 2-5 years’ of work experience and/or equivalent academic experience in a forensic or relevant industrial biomechanics position., • Experience working in the transportation industry, teaching experience, and/or in-depth knowledge of human anatomy., • Experience managing projects of moderate to substantial complexity and/or size., • Authoring of high-quality technical reports and/or peer-reviewed publications is highly preferred., • Delivery of technical presentations at professional conferences is highly preferred., • Preferred experience in the consulting industry. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is occasionally required to walk long distances, stand for extensive periods, negotiate irregular terrain, walk up and down stairs, and climb ladders; to utilize safety equipment including hard hats, hearing and eye protection, and safety harnesses; and to see, hear, and communicate audible or visible warnings. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is occasionally required to work outdoors, at night, in variable weather, at heights, alongside operating industrial machinery, and/or around or under damaged or exemplar equipment or vehicles. To all recruitment agencies: ESi does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of ESi without a prior written search agreement will be considered unsolicited and the property of ESi. Please, no phone calls or emails. It is the policy of ESi, as an equal opportunity employer, to attract and retain the best-qualified individuals available, without regard to race/ethnicity, color, religion, national origin, gender, sexual orientation, age, disability, or veteran status. ESi is committed to recruiting, hiring, and promoting people with disabilities, as well as veterans. If you need assistance with completing the electronic application, please email your request to .

Mechanical Project Engineer - Project Leader - Fortune 500 Metals Manufacturer This Jobot Job is hosted by: Jamal Elkhateib Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $115,000 - $125,000 per year A bit about us: We are a global innovator in advanced aluminum solutions, powering progress across aerospace, automotive, commercial transportation, and industrial markets. With one of the world’s largest integrated metal manufacturing operations—spanning 100+ acres under one roof—our teams design and produce materials that make vehicles lighter, aircraft more efficient, and structures stronger, all while advancing sustainability at every step of the value chain. Why join us? • Top-notch Compensation and Benefits package, • Up to 9% total match on 401k!, • Stable Career path, • Rewarding experience to work with Fortune 500 Company, • Excellent culture and peers, • 401K Match, • 3 weeks of vacation to start Job Details Relocation Support offered* The Impact Own end-to-end capital project delivery—from scope and funding through installation, commissioning, and hand-off. You’ll spend ~95% of your time planning and executing projects with vendors and contractors, ensuring safety, quality, schedule, and budget are met in a high-performance manufacturing environment. What You’ll Do Lead full lifecycle CAPEX projects: develop scope of work, build business case and funding documentation, create project schedules, and manage budgets. Partner with procurement and legal on project language, RFQs/POs, and vendor contracts. Direct daily activities of vendors/contractors and craft personnel during installation, startup, and commissioning. Drive change control, risk mitigation, and safe work practices; ensure compliance with site standards and regulations. Coordinate cross-functionally (operations, maintenance, EHS, quality, finance) to deliver results and seamless hand-offs. Track reliability and performance, leveraging measurement and statistical controls to verify capability and sustain improvements. Basic Qualifications (Required) BS in Mechanical, Aerospace, Agricultural, Electromechanical, or Biomedical Engineering (accredited). 7+ years in a manufacturing environment. Proven track record leading, managing, and executing projects—design through installation and commissioning. Experience managing external vendors and contractors for design, materials, installation, and related services. Legally authorized to work in the U.S.; employment eligibility verification required at time of hire. No visa sponsorship available. Export Control: Role requires access to controlled technology as defined by EAR/ITAR; government authorization may be required to meet compliance obligations. Preferred Qualifications 10+ years with manufacturing processes, ideally in the metals industry. Experience developing project business cases and capital approval requests. Proficiency with reliability techniques (measurement, statistical control, capability, maintainability). Strong theoretical and hands-on problem solving to correct issues and drive sustained improvements. Ability to oversee craft personnel and maintain an ongoing, productive dialog with installers to clarify requirements and ensure safe work practices. Excellent written and verbal communication; proven success coordinating and/or leading cross-functional teams. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. 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Job DescriptionPrincipal Electrical Engineer St. Louis Park, MN Job Summary We are seeking an experienced Principal Electrical Engineer to lead the electrical design and development of next-generation active implantable medical devices (AIMDs). This role involves architecting complex analog, digital, and mixed-signal circuits while ensuring compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross-functionally to translate clinical needs into manufacturable, high-performance products. Key Responsibilities • Lead the design, development, prototyping, and testing of electrical hardware for implantable devices, including analog/mixed-signal circuits, low-power electronics, power management systems, and wireless communication interfaces (e.g., BLE, RF telemetry)., • Architect system-level electrical designs, considering implantable constraints such as ultra-low power consumption, biocompatibility, miniaturization, hermetic packaging, and long-term reliability., • Perform circuit simulation, schematic capture, PCB layout oversight, and hardware verification/validation, including ISO14708 (e.g. EMC/EMI testing)., • Conduct risk analyses (e.g., dFMEA), root cause investigations, and failure mode testing to ensure device safety and efficacy., • Collaborate with cross-functional teams (firmware, mechanical, systems, clinical, and quality engineering) to integrate electrical subsystems and support closed-loop therapies., • Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, ISO14708, and IEC 60601 series., • Mentor and provide technical guidance to junior electrical engineers; lead design reviews and contribute to strategic technology roadmaps., • Support sustaining engineering for existing products, including troubleshooting, design improvements, and regulatory submissions., • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field., • 10+ years of experience in electrical hardware design for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class III devices)., • Expertise in analog and digital circuit design, low-power mixed-signal electronics, power electronics, and control systems., • Proven track record in medical device development, including full product lifecycle from concept to commercialization., • Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management.Preferred:, • Master's or Ph.D. in Electrical Engineering or related field., • Experience with neuromodulation, cardiac rhythm management, or closed-loop implantable systems., • Familiarity with ultra-low-power custom ASIC fabrication, wireless power transfer, or adaptive algorithms., • Experience and or understanding in embedded firmware design preferable, • Experience leading technical teams, design reviews, FMEA sessions, or regulatory audits., • Proficiency in tools such as Altium, SPICE simulation, MATLAB/Simulink, or similar.Skills and Competencies, • Excellent problem-solving and analytical skills with a focus on reliability and patient safety., • Strong communication skills for cross-functional collaboration and technical documentation. 6whCUYoMQq

Job Description Manufacturing Engineer Job Description: We are seeking a Manufacturing Engineer with at least 2 years of experience in a regulated manufacturing environment, preferably within the medical device industry, to support and enhance manufacturing operations with a strong focus on process validation planning and execution. This role is ideal for an engineer who already has hands-on validation experience and wants to deepen their expertise in medical device process validation while contributing to process development, improvement, and manufacturing scale-up. Responsibilities: • Support and execute process validation activities in compliance with FDA regulations and internal quality requirements., • Participate in validation planning by assisting with strategy development, risk assessments, protocol drafting, and planning reviews., • Support and execute validation activities, including IQ/OQ/PQ, data collection, data analysis, and preparation of validation reports., • Provide a technical perspective during validation planning by reviewing assumptions, approaches, and documentation to ensure robustness and compliance., • Apply experience from various validation requirements and manufacturing scenarios to strengthen validation strategies and execution., • Assist in planning, executing, and documenting Test Method Validation (TMV) activities to ensure methods are suitable and reliable., • Ensure test methods are repeatable, reproducible, and aligned with regulatory expectations., • Support process development and continuous improvement initiatives across manufacturing operations., • Assist in identifying opportunities to improve process capability, efficiency, and overall manufacturing flow., • Apply Lean manufacturing principles or similar methodologies to improve throughput and reduce waste., • Assist with manufacturing scale-up activities, including manufacturing flow optimization, capacity analysis, and maximum output and throughput projections., • Support readiness for increased production volumes and commercialization of products., • Work closely with Manufacturing, Quality, and Engineering teams to execute validation and improvement projects., • Collaborate with more engineers as a thought partner, incorporating feedback to strengthen planning and execution., • Contribute as an additional reviewer for validation planning and documentation to help ensure quality, completeness, and compliance., • At least 2 years of experience in manufacturing engineering within a regulated industry, preferably medical devices., • Hands-on experience supporting process validation activities, including planning and execution., • Experience with process validation planning and execution, including IQ/OQ/PQ., • Exposure to Test Method Validation (TMV)., • Familiarity with Lean manufacturing concepts and manufacturing flow., • Ability to support manufacturing process scale-up, including capacity analysis and throughput projections., • Strong technical documentation skills with the ability to write clear protocols, reports, and supporting documentation., • Solid data analysis skills to interpret validation and process data and support decision-making., • Bachelor’s degree in Engineering, such as Manufacturing, Mechanical, Biomedical, or a related field., • Experience in a medical device manufacturing environment or other highly regulated industries., • Experience applying Lean manufacturing principles or similar continuous improvement methodologies., • Ability to identify and implement process improvements to enhance capability, efficiency, and flow., • Interest in building deep expertise in medical device process validation, including both planning and execution., • Desire to learn and grow within a regulated environment, leveraging mentoring from experienced engineers., • Strong attention to detail and a quality-focused approach to validation and documentation. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.