Principal Systems & Safety Engineer

Location: Fridley, MN

Department: R&D NPD

About the role:

As a Principal Systems & Safety Engineer, you will play a critical role in ensuring our implantable neurostimulation systems are safe, reliable, and continuously improving. This is a highly impactful position that connects real-world product performance with next-generation innovation.

You’ll work at the intersection of systems engineering, safety, and post-market analysis, partnering across engineering, quality, and clinical teams to translate insights from the field into meaningful product and process improvements.

What you'll do:

Drive product safety and continuous improvement

• Lead investigations of returned implantable devices (IPGs, leads, and external systems)
• Conduct and guide advanced failure analysis to determine root cause and systemic risk implications
• Translate post-market insights into design improvements, risk file updates, and next-generation product requirements

Shape next-generation systems through engineering leadership

• Serve as a systems engineering lead across new product development and sustaining initiatives
• Evaluate design changes for technical, clinical, and regulatory impact, including PMA considerations
• Partner cross-functionally to ensure alignment across engineering, quality, and regulatory teams

Own risk management and regulatory excellence

• Lead development and maintenance of risk management documentation (FMEA, hazard analysis)
• Ensure compliance with key regulatory and quality standards (21 CFR 820/QMSR, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366)
• Maintain robust traceability across requirements, risk controls, verification activities, and labeling claims

Leverage data to inform strategy

• Support MDR and global vigilance reporting assessments
• Identify trends in product performance and proactively recommend corrective and preventive actions
• Contribute to reliability modeling and long-term product strategy

Qualifications

• Bachelor’s degree (or 7 years equivalent experience) in engineering or a related field
• Experience in Class II or Class III medical device development
• Strong background in systems engineering, design controls (21 CFR 820.30), and risk management (ISO 14971)
• Experience with complaint handling, MDR reporting, and complex failure/root cause investigations

• Experience with implantable or active neurostimulation systems (IPGs, leads, external devices)
• Deep knowledge of FDA, ISO, and IEC standards and regulatory frameworks
• Experience working across the full product lifecycle within a regulated environment

You’ll thrive in this role if you are:

• A technically strong problem solver who enjoys investigating complex system-level issues
• Highly collaborative and effective working across cross-functional teams
• Detail-oriented with a strong commitment to quality, compliance, and patient safety
• Adaptable and energized by working in a fast-paced, evolving environment
• A credible technical leader who can influence decisions and drive outcomes

Equal Opportunity Employer

Mobia Medical, Inc. 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 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

About the Company

About Mobia Medical

Mobia Medical is a commercial-stage medtech company delivering breakthrough stroke recovery solutions. The company’s Vivistim® Paired VNS™ Therapy is the first and only FDA-approved implantable solution designed to improve function in chronic ischemic stroke survivors with moderate to severe upper limb impairments. Vivistim® Paired VNS™ Therapy combines targeted vagus nerve stimulation with functional movement to promote neuroplasticity and improve the brain’s ability to relearn motor skills. Mobia Medical is mobilizing patients, providers, and care partners to establish a better way forward in stroke care.