Principal Systems & Safety Engineer

MicroTransponder • Fridley, MN

1d

About The Position

At Mobia Medical (formerly MicroTransponder), we’re transforming stroke recovery through our Vivistim® System, the first FDA-approved paired vagus nerve stimulation platform designed to improve hand and arm function for stroke survivors.
As a Principal Systems & Safety Engineer, you will play a critical leadership 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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 11-50 employees