Principal Design Assurance Engineer

MicroTransponder; Fridley (MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental and vision plans

401(k) with company match

Unlimited PTO

18 holidays per year

Job summary

Mobia Medical seeks a Principal Design Assurance Engineer to lead hardware and electrical medical device design assurance across development stages. You will bridge Design Engineering and Quality, ensure DHF maintenance, and guide risk management and regulatory compliance.

The role requires 10+ years in regulated environments, expertise in design controls, V&V, and strong communication. Candidates should be adept at investigations, CAPA, audits, and cross-functional collaboration.

Qualifications

• Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related field 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 DHF maintenance, verification and validation testing, and test method development.
• 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.
• Support post-market sustaining activities including failure analysis, design change development and implementation, supplier 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.

Skills

Electrical Engineering

Biomedical Engineering

Mechanical Engineering

Regulatory Compliance

Education

Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related field

Job description

About this position

About Mobia

MobiaMedical is a commercial-stage medtech companydelivering breakthrough stroke recovery solutions. The company’sVivistim® Paired VNS™ Therapy is thefirst and only FDA-approved implantable solution designedto improve function in chronic ischemic stroke survivorswith moderate to severe upper limb impairments. Vivistim® Paired VNS™ Therapy combines targetedvagusnerve stimulation with functional movement to promoteneuroplasticity and improve the brain's ability to relearnmotor skills. MobiaMedical is mobilizing patients, providers, and carepartners toestablisha better way forward in stroke care.

About the role

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.

What you'll do

• 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

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:
• 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

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.

Mobia Medical 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.

Benefits

Mobia Medical 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.

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