MedTech Design Quality Engineer - Risk and Verification Lead

RQM+; Maple Grove (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Industry-leading compensation package

Ongoing learning and development opportunities

Focus on work-life balance

Job summary

A leading MedTech firm in Maple Grove is seeking a Design Quality Engineer to oversee design controls and risk management in product development. This role requires significant experience in medical device quality, and the ability to collaborate closely with R&D. Candidates must have a Bachelor’s degree in Engineering and 5–8 years of experience in quality or design engineering. Join a team that values innovation and quality assurance, making impactful contributions to patient health and safety.

Qualifications

• 5–8+ years of experience in medical device quality or design engineering.
• Strong hands-on experience with design controls and design risk management.
• Experience supporting and approving design verification and validation activities.

Responsibilities

• Act as the Design Quality representative on R&D projects.
• Review and approve all R&D changes to the Design History File.
• Lead and maintain design risk management activities in accordance with ISO 14971.

Skills

Design control compliance

Risk management expertise

Strong communication skills

Team collaboration

Education

Bachelor’s degree in Engineering or related discipline

Tools

DFMEAs

ISO 14971

21 CFR 820

ISO 13485

Job description

A leading MedTech firm in Maple Grove is seeking a Design Quality Engineer to oversee design controls and risk management in product development. This role requires significant experience in medical device quality, and the ability to collaborate closely with R&D. Candidates must have a Bachelor’s degree in Engineering and 5–8 years of experience in quality or design engineering. Join a team that values innovation and quality assurance, making impactful contributions to patient health and safety.