Job Description & Details
This is a hands-on regulatory and product development role where you will actively shepherd medical devices through strict compliance frameworks. If you enjoy bridging the gap between rigorous engineering design and FDA/ISO standards without getting bogged down by endless meetings, this is a solid gig.
What You'll Actually Be Doing
You will spend your days driving engineering studies, writing technical documentation, and applying statistical methodologies to validate medical devices. Expect to collaborate closely with cross-functional teams to ensure designs comply with 21 CFR Part 820 and ISO 13485, while troubleshooting real-world material or software-as-a-medical-device (SaMD) challenges.
The Core Tech Stack
You need a deep working knowledge of medical device standards like ISO 14971, IEC 62366-1, and BS EN 62304. Experience with statistical software like Minitab for Design of Experiments (DOE) and sample size rationale is non-negotiable, as you will need to mathematically back up every engineering claim you make.
Interview Expectations
Expect the hiring team to ask you to walk through a specific time you managed a risk assessment under ISO 14971 for a complex design change. They want to hear how you handled conflicting priorities between time-to-market and compliance without cutting corners. Another likely grilling will involve explaining your rationale for sample size determination during a hypothesis test, so be ready to defend your statistics.
Application Advice
Your resume needs to heavily feature exact standard codes like 21 CFR Part 820, ISO 13485, and ISO 14971 to clear the automated screening filters. Highlight specific projects where you applied DOE and Minitab in regulated medical device environments rather than just listing them as general skills.