Quality Engineer

A venture-backed, clinical-stage medical device innovator is advancing a minimally invasive, catheter-delivered Class III implantable system for structural heart disease. You'll join a small, high-ownership team at an exciting inflection point-helping build and execute validation work that directly impacts patient outcomes and accelerates the path to commercialization.

What you'll do:

• Execute process validations (IQ/OQ/PQ): run studies, collect/analyze data, and drive compliant documentation.
• Draft and maintain validation protocols and reports; help identify critical process parameters (CPPs).
• Support process risk management: create/refresh PFMEAs, participate in risk reviews, and document mitigations.
• Partner with Manufacturing/Operations during design transfer, validation builds, supplier qualification, and special processes (including sterilization documentation).

Qualifications / Requirements:

• Bachelor's degree in Mechanical, Biomedical, Industrial Engineering (or related).
• 5+ years (ideal) in Quality or Manufacturing/Process Development within regulated medical devices; 3-7+ years considered for a true "hit-the-ground-running" candidate.
• Hands-on experience generating and executing validations (not just reviewing): IQ/OQ/PQ, PFMEA, IMV/TMV, plus CAPA support/root cause analysis.
• Working knowledge of statistics; strong Excel skills;
  Minitab preferred.
• Comfortable in a pre-commercial environment with time in office + manufacturing/cleanroom; strong communication and documentation habits.

Nice to have:

• Experience with catheter-based devices, heart valves, or other Class III implantables.