Quality Engineer

Join Our Next-Generation Structural Heart Company

This is an opportunity to join an innovative medical device startup developing Class III implantable valve and catheter-based delivery technologies that are advancing the future of cardiovascular care.

They are looking for a hands-on Quality Engineer who thrives in fast-paced, collaborative environments and wants broad exposure across validation, risk management, manufacturing, supplier quality, and product commercialization.

This is NOT a narrow sustainment role.

You'll work closely with Quality, Manufacturing, and R&D leadership to help build scalable processes, support product launch activities, and contribute directly to a growing organization where your work will truly matter.

Lead/support process validations (IQ/OQ/PQ) Develop validation protocols and reports Support PFMEA and risk management activities Execute Gage R&R / MSA studies Support design transfer and manufacturing builds Partner cross-functionally during product development and commercialization Support supplier quality and special process validations Participate in root cause investigations, CAPA, and continuous improvement activities

BS Engineering preferred 3–7+ years in Quality or Manufacturing Engineering within medical devices Experience with process validation, PFMEA, IMV/TMV activities Strong understanding of manufacturing and inspection processes Comfortable in a startup / pre-commercial environment Class III and/or catheter-based device experience highly preferred

Early-stage company with significant growth potential High visibility and direct impact Broad technical exposure across multiple quality disciplines Collaborative, highly engaged leadership team Opportunity to help shape systems and processes versus simply maintain them

If you enjoy wearing multiple hats, solving problems, and helping build something meaningful, this could be a very exciting next step.