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.