Want to help build a next-generation structural heart company from the ground up?
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.
Your role with the company:
• 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
Desired profile:
✓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
What Makes This Role Exciting:
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.