Principal Design Assurance Engineer

About Mobia

Mobia Medical is a commercial-stage medtech companydelivering breakthrough stroke recovery solutions. The company’s Vivistim® 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 targeted vagusnerve stimulation with functional movement to promoteneuroplasticity and improve the brain's ability to relearnmotor skills. Mobia Medical is mobilizing patients, providers, and carepartners to establish a 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:
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
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.

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.

Apply now

The Pay Range For This Role Is

110,000 - 160,000 USD per year(US National)
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