Principal Post Market Surveillance Engineer

Location: Fridley, MN

Department: Quality

About the role

In this role, you will lead post-market surveillance activities, serving as a subject matter expert in complaint handling, adverse event reporting, and regulatory compliance. You will partner cross-functionally with Clinical, Regulatory, Engineering, and Commercial teams to evaluate product performance, drive continuous improvement, and ensure that real-world data informs product quality and future development.

What you'll do

Lead post-market surveillance and complaint handling

• Coordinate and manage the complaint handling process, including intake, risk assessment, investigation, and resolution
• Oversee disposition of field experience reports and coordinate cross-functional investigations
• Determine adverse event reportability and prepare/submission of Medical Device Reports (MDRs)
• Serve as the subject matter expert for complaint handling and MDR reporting during regulatory inspections and audits

Drive quality, compliance, and risk management

• Maintain and monitor complaint metrics, ensuring signals are identified, triaged, and escalated appropriately (e.g., HHE, CAPA)
• Lead and/or support CAPA investigations, including root cause analysis, corrective actions, and effectiveness checks
• Provide key inputs into Risk Management Files and product development processes

Leverage data to improve product performance

• Support post-market data collection, trending, and performance monitoring
• Author post-market surveillance plans and reports
• Translate data insights into recommendations that drive quality and operational improvements

Collaborate cross-functionally

• Partner with Clinical, Regulatory, Engineering, Commercial, and supplier quality teams to resolve product issues
• Support internal audits and regulatory inspections by providing documentation and expertise
• Communicate findings and recommendations across the organization

Drive continuous improvement

• Identify and lead initiatives to improve complaint handling processes, quality systems, and regulatory compliance
• Enhance efficiency and effectiveness of post-market surveillance activities

Qualifications

• Bachelor’s degree in a relevant field with 10+ years of progressive experience in medical device quality, with a strong focus on post-market surveillance
• Deep experience with complaint handling, adverse event reporting, and quality systems processes
• Strong knowledge of medical device regulations and standards (cGMP, FDA 21 CFR Parts 803, 806, 820/QMSR, ISO 13485)
• Proven experience leading investigations, CAPA activities, and root cause analysis
• Strong analytical, problem-solving, and organizational skills

Preferred qualifications:

• Experience, training, or certification in quality engineering
• Experience with electronic Quality Management Systems (eQMS), such as Grand Avenue Software

You’ll thrive in this role if you are:

• A subject matter expert who can confidently lead during audits and regulatory inspections
• Detail-oriented with a strong commitment to quality and compliance
• A collaborative partner who works effectively across cross-functional teams
• A strategic thinker who can translate data into actionable insights
• Proactive in identifying opportunities for continuous improvement

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

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.