Lead design quality on software projects, ensuring QMS compliance.
Review and approve design docs: user needs, specs, architecture, and V&V.
Ensure design controls comply with ISO 13485, IEC 62304, and FDA 21 CFR Part 820.
Manage risk per ISO 14971 through the product lifecycle.
Collaborate with engineering to ensure robust, well-documented SDLC test methods.
Maintain the DHF for projects, audits ready.

🎯 Requirements

Bachelor’s degree in engineering, computer science, or related field.
12+ years of Design Quality/Quality Engineering in medical devices (SaMD).
ISO 13485 knowledge with Product Realization experience.
IEC 62304 and ISO 14971 experience.
FDA QSR (21 CFR Part 820) and EU MDR familiarity.
Hands-on experience with GitHub, TestRail, and CI/CD pipelines.

🎁 Benefits

Stock options, benefits, and employee perks are part of total rewards.
Remote-first environment with occasional on-site meetings/travel.
Equal opportunity employer.

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