Quality Engineer – Med Device Startup, High-Impact Role

Custom Search Inc.; Maple Grove (MN); On-site; USD 70,000 - 110,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Process validation

PFMEA

Gage R&R

MSA

Education

BS Engineering

Job description

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