Job Description
About the Role
We're a medical device company looking for an experienced product engineer who understands that in this industry, how you build is just as important as what you build. We need someone who can move fast without cutting corners on compliance — equally comfortable writing code or specs as they are maintaining the documentation required for regulatory submissions. This is not a pure regulatory affairs role; it's a hands-on engineering position with compliance built in.
What You'll Do
Develop and iterate on product features with a clear understanding of design control requirements under 21 CFR Part 820 and ISO 13485
Maintain and contribute to the Design History File (DHF), including requirements traceability, risk management documentation per ISO 14971, and test protocols
Participate in design reviews and support verification & validation (V&V) activities
Identify and flag compliance risks early in the development cycle
Coordinate with QA and regulatory affairs stakeholders to ensure engineering decisions are properly documented
Write clear, traceable requirements that hold up under audit
Apply Now
Apply Now