Principal Design Assurance Engineer

MicroTransponder • Fridley, MN

3d

About The Position

The Principal Design Assurance Engineer supports product design and development activities and ensures the effective transfer of new products into manufacturing. This role partners closely with Regulatory, Operations, and Engineering teams to ensure compliance with applicable regulatory requirements and company standards.
The position is responsible for lifecycle management of assigned products, including maintenance of Design History Files (DHF) and Design Risk Management documentation.
This role applies hands-on electrical engineering expertise to support the design, analysis, verification, and sustaining of medical devices, including analog and digital circuits, power management, embedded systems, and electromechanical interfaces. The engineer interprets and evaluates electrical schematics, PCB layouts, component selection, and design tradeoffs to ensure alignment with design inputs, risk controls, and regulatory requirements.
The role serves as a technical bridge between Design Engineering and Quality by providing informed review and challenge of electrical design decisions.
In addition, this position supports nonconformance, CAPA, and complaint investigations and acts as a subject matter expert in hardware and electrical design controls, product and system risk management, robust design practices, test method development and validation, and technical investigations.

Requirements

• Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related discipline with 10+ years of progressive experience, or equivalent combination of education and experience
• Experience applying hardware and electrical design controls in regulated industries
• 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 applicable regulations and standards, including: FDA 21 CFR Part 820 ISO 13485 ISO 14971 IEC 60601 IEC 61010 (as applicable) ISO 10993 (as applicable) EU MDR
• Strong analytical and problem-solving skills
• Ability to work independently while exercising sound judgment
• Proficiency with Microsoft Office and engineering/documentation tools
• Strong organizational and time-management skills
• Demonstrated success achieving quality and compliance objectives

Nice To Haves

• Quality engineering experience or certification preferred

Responsibilities

• Provide Design Assurance leadership throughout the design and development of new hardware and electrical medical device products
• Support post-market sustaining activities including failure analysis, design change development and implementation, supplier performance evaluation, certifications, complaint investigations, and nonconformance disposition
• Lead root cause investigations, corrective action development, and verification of effectiveness
• Lead and support compliant development, verification, validation, and transfer of new products and processes into manufacturing
• Serve as a subject matter expert in hardware and electrical design controls, risk management, verification & validation, and DHF maintenance
• Support new process development, test method development and validation, process characterization, and technical investigations
• Lead and participate in design verification and validation activities with clear documentation
• Ensure hardware and electrical designs meet regulatory and company standards for quality, safety, performance, and reliability
• Apply sound engineering methodologies to resolve technical issues and drive improvements
• Collaborate with Product Development, Sustaining Engineering, Quality, Regulatory, and Operations teams
• Participate in design reviews and phase-gate reviews
• Contribute to project planning, cost estimates, schedules, and performance requirements
• Prepare and deliver technical presentations
• Provide leadership and mentoring to engineers and project team members
• Support audits and regulatory inspections
• Provide backup support for other QA functions
• Perform other duties as assigned

Benefits

• MicroTransponder provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 18 paid company holidays per year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level