Principal Systems & Safety Engineer

About Mobia

Mobia Medical, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The company's flagship product, the FDA-approved Vivistim® Paired VNS™ System, enhances stroke rehabilitation by pairing vagus nerve stimulation (VNS) with physical and occupational therapy. This approach leverages the brain's neuroplasticity to improve upper limb function, offering new hope to those with chronic arm and hand impairments following an ischemic stroke.

By integrating this therapy into rehabilitation programs, Mobia aims to help stroke survivors regain independence in daily activities and enhance their quality of life. The company's commitment to advancing stroke recovery is evident in its ongoing research and collaboration with healthcare providers to make this therapy accessible to more patients.

About the role:

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.

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 outcom