Quality Engineer

Custom Search Inc.; Maple Grove (MN); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Custom Search Inc. in Maple Grove, MN is seeking a hands-on Quality Engineer to join a fast-paced medical device startup developing Class III implantable valve and catheter-based delivery technologies.

You will gain broad exposure across validation, risk management, manufacturing, supplier quality, and product commercialization to help scale operations beyond initial launch. This role is not a narrow sustainment position; you will lead validations, collaborate with Quality, Manufacturing, and

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Process validation

PFMEA

Gage R&R

MSA

Educación

BS Engineering

Descripción del empleo

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.