Principal Design Assurance Engineer

About the role

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.

Qualifications

• 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
• 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 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

Pay

The pay range for this role is: 110,000 - 160,000 USD per year (US National)

Benefits

• Medical, dental, and vision plans
• Flexible Spending Account (FSA)
• Company 401(k) plan with company matching
• Unlimited Paid Time Off (PTO) program
• Approximately 18 paid company holidays per year

Equal Opportunity Employer

Mobia Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.