Senior Medical Device Regulatory & Certification Engineer
SharkNinja
SharkNinja in Needham, Massachusetts, is seeking a Senior Product Safety & Compliance Engineer to manage regulatory compliance and product certification across various product lines, including medical devices. You will be responsible for certification activities, preparing regulatory filings, leading project reviews, and ensuring compliance with FDA and EU standards. The ideal candidate should have a bachelor's degree in engineering and at least 5 years of experience in compliance. #J-18808-Ljbffr SharkNinja
$92.2k - $141.4k
Job Overview The Senior Product Safety & Compliance Engineer will partner with global product developers and certification partners to manage regulatory compliance and product certification from... ...production. This role supports medical device compliance alongside consumer...SeniorRegulatoryMedical deviceLocal areaFlexible hoursShift work- ...Senior Manufacturing Engineer Medical Device About the job Senior Manufacturing Engineer Medical Device The Senior... ...emphasizes efficiency, quality, regulatory compliance, and cost-... ...Preferred Skills: Lean and/or Six Sigma certifications. Expertise in catheter fabrication...SeniorRegulatoryMedical deviceContract workWork at office
$102.48k - $163.97k
...Quality Systems Engineer The Quality Systems Engineer... ...and meets the regulatory requirements. Analyzes... ...findings to senior management. Contributes... ...regulated (ISO 13485) medical device quality operations/manufacturing... ..., ISO Lead Auditor certifications-desired. You must...SeniorRegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$83 - $84 per hour
...opportunity to extend The Senior Systems Engineer will serve as a technical... ...pipeline of wearable medical devices, including cloud‑based and... ...manufacturing, marketing, clinical, regulatory, and quality teams.... ...training and/or certification is a plus. 1–2 years of experience...SeniorRegulatoryMedical deviceContract work$120k - $200k
...activities. Assist with EMC and safety certification processes to meet regulatory standards in the US and EU.... ...Bachelor\'s degree in Electrical Engineering. Minimum of 5 years of experience... ...electronic systems in consumer or medical device industries. Proven ability to...SeniorRegulatoryMedical deviceLocal area$89.2k
...Best Workplaces for Engineers in 2026, reflecting a... ...experience every day. The Senior Quality Systems... ...updates, regulatory implementation activities... ...qualifications: • Medical device industry experience preferred... ...licensure and certifications, among other relevant...SeniorRegulatoryMedical deviceHourly payPermanent employmentWork at officeLocal areaRelocationRelocation packageShift work3 days per week$90k - $110k
...where applicable, certifications. The successful candidate... .... Benefits Day-1 medical, supplemental... ...and so much more. Senior Quality Operations Engineer - Quality Operations... ...for product quality, regulatory compliance,... ...regulated medical device or IVD environment....SeniorRegulatoryMedical deviceFull timeFlexible hours- ...and electromechanical devices. This includes hands‑... .... Key Skills Medical Device Manufacturing... ...delivery timelines, and regulatory compliance capabilities... ...by Management. Review engineering product specifications... ...Lean and/or Six Sigma certifications preferred. #J-18808-...SeniorRegulatoryMedical deviceContract workWork at office
$115k - $165k
A leading medical device company based in Massachusetts is seeking a Principal Manufacturing Engineer to lead new product introductions and define robust manufacturing processes... ..., collaboration, and compliance with regulatory standards. #J-18808-Ljbffr Fractyl HealthSeniorRegulatoryMedical device- ...a skilled professional to develop and lead design verification and validation (V&V) strategies for medical devices. This role entails ensuring compliance with regulatory standards, overseeing the execution of test activities, and maintaining documentation integrity. The...SeniorRegulatoryMedical device
$140k - $185k
A leading staffing firm is seeking a Quality Engineer to lead product lifecycle quality initiatives in Bedford,... ...requires a bachelor's degree in engineering, 9+ years in medical devices, a strong understanding of regulatory standards, and proficiency in quality management...SeniorRegulatoryMedical device- A medical technology firm in Cambridge, Massachusetts is seeking a seasoned Validation Engineer with over 10 years of experience in regulated manufacturing. The ideal candidate... ...existing processes, and must be proficient in regulatory compliance with standards such as ISO 134...SeniorRegulatoryMedical device
$92k - $148.35k
...&D Software/Systems Engineering Job Category Scientific... ...team as a Senior Robotics Verification... ...part in supporting regulatory submissions and product... ...test plans for complex medical devices, including system verification... ...Skills, Abilities, Certifications/Licenses And...SeniorRegulatoryMedical deviceWork at officeLocal areaImmediate start3 days per week- Werfen in Bedford, MA is seeking a Senior Software Quality Engineer to ensure product lifecycle compliance with regulatory standards. You will develop and implement methods, tools, and practices across design, development, cybersecurity, verification and validation, and...SeniorRegulatoryMedical device
- Precision Optics Corporation Inc is seeking a Senior Manufacturing Engineer in Littleton, Massachusetts. The role involves designing and developing... ...improvement projects, and ensuring compliance with regulatory standards. Candidates should have over 8 years of manufacturing...SeniorRegulatoryMedical device
- A growing medical device company is seeking a Senior Quality Engineer to lead design quality for new product development. This role requires collaboration with R&D and engineering to ensure compliance with regulatory standards like FDA and ISO 13485. Ideal candidates have...SeniorRegulatoryMedical deviceFull time
$130k - $160k
...company in Massachusetts is seeking a Senior Software Quality Engineer responsible for ensuring product... ...over 8 years of experience in the medical devices or diagnostic industry, demonstrating... ...quality management techniques and regulatory compliance. This role offers a competitive...SeniorRegulatoryMedical device- IPG Medical is seeking a Senior Mechanical Engineer to lead the development of complex medical devices in Marlborough, Massachusetts. The ideal candidate will have a minimum of 10... ...transfers, and ensuring compliance with global regulatory standards. A BS in Mechanical...SeniorRegulatoryMedical device
$120k - $140k
...exciting opportunity to join a growing medical device company at a key point in its... ...built in from the start. If you’re a Senior Quality Engineer who enjoys partnering closely with R... ...management, verification and validation, and regulatory readiness. Key Responsibilities Act...SeniorRegulatoryMedical deviceFull time- Analog Devices, Inc. seeks a hands-on Senior Design Quality Engineer to own QA activities across the product lifecycle, from... ...verification and validation, and regulatory requirements, while aligning... ...continuous improvement in a fast-paced medical device environment. #J-18808-...SeniorRegulatoryMedical device
- ...About the job Senior Manufacturing Engineer Hello, Client: Manufacturing Industry Position: Medical Device Senior Manufacturing Engineer Location: Cambridge, MA... ...quality, cost, delivery timelines, and regulatory compliance capabilities to recommend...SeniorRegulatoryMedical deviceContract work
$90.1k - $153.3k
...Haemonetics designs and manufactures medical devices that separate blood... ...Sr Mechanical Design Engineer for the overall concept, design... ...understanding of medical device regulatory requirements and standards... ..., simulation analysis, and certification for IEC safety and EMC...SeniorRegulatoryMedical deviceHourly payTemporary workSummer workMonday to FridayFlexible hours- ...Senior Mechanical Engineer - Medical Devices Duties Lead development of complex medical devices and subsystems through all development phases from design... ...products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations...SeniorRegulatoryMedical deviceWork experience placement
- A partner developing innovative medical products in Boston is looking for a Senior Electrical Engineer. This role involves leading electrical engineering efforts throughout... ...-signal circuits, and ensuring compliance with regulatory standards. The ideal candidate has at least 6...SeniorRegulatoryMedical deviceRemote jobFlexible hours
- ...Scientific is looking for a Supplier Quality Engineer III in Marlborough, Massachusetts. This... ...audits, and ensuring compliance with regulatory standards. Candidates should have a BS... ...relevant experience, preferably in the medical device industry. The position supports a...SeniorRegulatoryMedical deviceRemote work
- Philips is looking for a Senior Electrical Engineer in Bedford, Massachusetts to join their team. The ideal candidate... ...s degree, and a minimum of 5 years in the medical devices industry. Experience with schematic capture, regulatory standards, and testing is highly desirable...SeniorRegulatoryMedical deviceFull time
- Axoft in Cambridge, MA is seeking a Senior Embedded Systems Engineer to lead firmware development for implantable brain-machine interfaces. This... ...systems, ensuring safety, reliability, and compliance with regulatory standards. The ideal candidate will have over 5 years of...SeniorRegulatoryMedical device
- A leading medical technology firm in Acton, MA, is seeking a Senior Systems Engineer to lead the design and development of innovative wearable medical devices. This role involves collaborating with cross... ...disciplines and experience with regulatory standards. This contract...SeniorRegulatoryMedical deviceHourly payContract work
- ...Senior Process Engineer The Senior Process Engineer leads diverse process improvement initiatives... ...process development projects for medical devices and drug products. Acting as a... ...support process validation activities for regulatory approval and new product...SeniorRegulatoryMedical device
- A leading technology firm is seeking a Senior Medical Device Software Engineer experienced in Python and C++ to design and optimize high-performance... ...engineers, all while ensuring compliance with clinical and regulatory standards. Located in Boston, you will work in a...SeniorRegulatoryMedical deviceFull time
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