> Markdown version of [/jobs/ext/2534659-design-assurance-engineer-medical-devices](https://www.wearedevelopers.com/jobs/ext/2534659-design-assurance-engineer-medical-devices). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Assurance Engineer / Medical Devices - **Company:** Motion Recruitment Partners LLC. - **Location:** Marlborough, MA, United States - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Analysis of Variance (ANOVA), Failure Mode Effects Analysis, Minitab, Verification and Validation (Software), Test Data, Iq/oq/pq - **Published:** August 18, 2026 - **Apply:** https://www.dice.com/job-detail/10315044-81b2-4704-928f-bbb7be61b3ae ## About the Role This is a great opportunity for an engineer with 3-5 years of medical device experience who wants to take on meaningful work across the full product development lifecycle. You'll help develop and improve Class II electro-mechanical medical devices while working closely with Design Engineering, Quality, Regulatory, and external testing teams., * Bachelor's degree in Electrical Engineering, Engineering, or a related scientific field * 3-5 years of Class II medical device experience * Experience with Design Controls and Risk Management * Experience with verification and validation * Experience with EMC, EMI, and IEC compliance testing * Experience with DFMEA/PFMEA and technical documentation * Strong communication and documentation skills * Proficiency with Microsoft Word and Excel Nice to Have * FDA QSR experience * ISO 13485 and ISO 14971 * IEC 60601, IEC 60825, IEC 62366, or IEC 62304 * IQ/OQ/PQ experience * FDA or CE submission experience * Minitab or other statistical software * DOE, ANOVA, Gage R&R, or capability analysis * Experience with lasers, optics, or photonics Tech Breakdown 30% - Design Controls & Risk Management 25% - Verification & Validation 20% - Regulatory & Compliance 15% - Technical Documentation 10% - Statistical Analysis & Testing Applicants must be currently authorized to work in the U.S. on a full-time basis now and in the future. ## Description You'll have the opportunity to work on products from early design and risk assessment through verification, validation, compliance testing, and commercialization. Why This Role? * Work on advanced Class II electro-mechanical medical devices * Be involved throughout the full product development lifecycle * Work closely with Engineering, Quality, and Regulatory teams * Take ownership of design assurance, risk management, V&V, and compliance activities * Gain exposure to FDA, CE, ISO, and IEC requirements * Work with external testing organizations including TV and Intertek * Exposure to lasers, optics, and photonics is a plus What You'll Be Doing * Support design control and risk management activities * Perform and support DFMEA and PFMEA activities * Develop and execute verification and validation protocols * Support IQ/OQ/PQ and other validation activities * Coordinate EMC, EMI, and IEC compliance testing * Work with external test laboratories * Maintain design history files and technical documentation * Support FDA, CE, and other regulatory submissions * Analyze test data and help engineering teams make design decisions * Collaborate with Design Engineering, Quality, Regulatory, and external partners ## Related Videos - [Dirty Tests And How To Clean Them](https://www.wearedevelopers.com/videos/515-dirty-tests-and-how-to-clean-them) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Stop Guessing, Start Measuring: Evaluating RAG Systems with Synthetic Test Data](https://www.wearedevelopers.com/videos/1982-stop-guessing-start-measuring-evaluating-rag-systems-with-synthetic-test-data) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [Modern Data Architectures need Software Engineering](https://www.wearedevelopers.com/videos/1030-modern-data-architectures-need-software-engineering) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market)