> Markdown version of [/jobs/ext/2606325-medical-device-design-quality-engineer](https://www.wearedevelopers.com/jobs/ext/2606325-medical-device-design-quality-engineer). 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).

---

# Medical Device Design Quality Engineer

- **Company:** VIR Healthway LLC
- **Location:** Newton, MA, United States
- **Experience:** Expert
- **Salary:** $135,200.0 - $145,600.0
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Minitab, Statistics Packages
- **Published:** August 2, 2026
- **Apply:** https://www.healthjobsnationwide.com/node/15398454/apply-external

## About the Role

* Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
 * 7-10 years' experience in Design Quality within medical devices (Class III preferred).
 * Strong knowledge of Design Controls, QSR, ISO 13485, ISO 14971.
 * Experience with Minitab or statistical analysis tools.
 * Familiarity with ESD controls, electrical components handling.
 * Strong technical writing, communication, and time management skills.

## Description

Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle., * Serve as Quality representative and Design Controls lead on cross-functional teams.

 * Ensure compliance with FDA QSR (21 CFR 820.30), ISO 13485, MDR/MDD, and global regulations.
 * Lead risk management per ISO 14971, including system-level risk analysis, FMEA/SWFMEA, and residual risk evaluation.
 * Maintain end-to-end traceability between design inputs/outputs, risk controls, and verification & validation (V&V).
 * Review/approve V&V protocols and reports; support tolerance, worst-case, and margin analyses.
 * Support IEC 60601-1, IEC 60601-1-2, IEC 80601-2-77 electrical safety/EMC compliance.
 * Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304.
 * Support supplier qualification, design transfer, and DHF completeness.
 * Contribute to IDE, De Novo, PMA submissions.
 * Lead CAPA, NCMR, complaint investigations, and root cause analysis.


## Related Videos

- [The Algorithm That Nearly Killed Me: When Testing Isn't Enough](https://www.wearedevelopers.com/videos/2110-the-algorithm-that-nearly-killed-me-when-testing-isn-t-enough)
- [Challenges of building React and React Native apps](https://www.wearedevelopers.com/videos/448-challenges-of-building-react-and-react-native-apps)
- [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build)
- [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips)
- [May I interest you in ... R?](https://www.wearedevelopers.com/videos/445-may-i-interest-you-in-r)
- [What Developers Get Wrong About Application Quality](https://www.wearedevelopers.com/videos/233-what-developers-get-wrong-about-application-quality)

## Related Articles

- [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk)
- [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)
- [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)
- [What Jobs Can You Get with a Software Engineering Degree?](https://www.wearedevelopers.com/magazine/398-what-jobs-can-you-get-with-a-software-engineering-degree)
- [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)
- [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer)