Lead Design Assurance Engineer — MedTech Hardware

Mobia Medical; Minneapolis (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Mobia Medical is seeking a senior electrical engineer to lead design assurance for new hardware and electrical medical devices. You will drive risk management, DHF maintenance, and verification/validation activities across development and post-market support.

The role requires deep knowledge of FDA/ISO standards, strong collaboration with cross-functional teams, and a track record of delivering compliant, high-quality medical devices.

Qualifications

• Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related discipline with 10+ years of progressive experience.
• Experience applying hardware and electrical design controls in regulated industries.
• Quality engineering experience or certification preferred.
• Strong knowledge of medical device design controls, risk management, new product development, DHF maintenance, verification and validation testing.
• Experience with test method development and validation.
• Strong communication skills with ability to explain technical concepts clearly.
• Demonstrated ability to lead technical teams through collaboration and influence.
• In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 61010, ISO 10993, EU MDR.

Responsibilities

• Provide design assurance leadership throughout the design and development of new hardware and electrical medical device products.
• Lead post-market sustaining activities including failure analysis, design changes, supplier performance evaluation, certifications, investigations.
• Lead root cause investigations, corrective action development, and verification of effectiveness.
• Lead and support compliant development, verification, validation and transfer of new products into manufacturing.
• Serve as SME in hardware and electrical design controls, risk management, verification & validation, and DHF maintenance.
• Support test method development and validation, process characterization, and technical investigations.
• Lead design verification and validation activities with proper documentation.
• Ensure hardware and electrical designs meet regulatory and company standards for quality, safety, performance.
• Collaborate with Product Development, Sustaining Engineering, Quality, Regulatory, and Operations teams.
• Participate in design reviews and phase-gate reviews.
• Prepare and deliver technical presentations; provide mentoring to engineers.
• Provide backup support for other QA functions; support audits and regulatory inspections.

Skills

Regulatory compliance

Electrical design controls

Risk management

Product development

DHF maintenance

Verification & validation

Test method development

Technical leadership

Regulations knowledge

Analytical skills

Independent work

Documentation tools

Communication skills

Education

Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering or related with 10+ years experience

Job description

Mobia Medical is seeking a senior electrical engineer to lead design assurance for new hardware and electrical medical devices. You will drive risk management, DHF maintenance, and verification/validation activities across development and post-market support.

The role requires deep knowledge of FDA/ISO standards, strong collaboration with cross-functional teams, and a track record of delivering compliant, high-quality medical devices.