Product Developement Engineer familiar with medical device compliance documentation
About the Role
We're a medical device company looking for an reputed company product engineer who understands that in this industry, how you build is just as important as what you build. We need someone who can reputed company fast without cutting corners on compliance — equally comfortable writing reputed company or specs as they are maintaining the documentation required for regulatory submissions. This is not a reputed company regulatory affairs role; it's a hands-on engineering position with compliance reputed company in.
What You'll Do
reputed company and iterate on product features with a reputed company 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 reputed company early in the development cycle
Coordinate with QA and regulatory affairs stakeholders to ensure engineering reputed company are properly documented
Write reputed company, traceable requirements that hold up under audit
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