Principal Post Market Surveillance Engineer

Mobia Medical • Fridley, MN

1d

About The Position

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.

Requirements

• 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

Nice To Haves

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

Responsibilities

• 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

Benefits

• medical
• dental
• vision plans
• FSA
• 401(k) plan with company matching
• unlimited Paid Time Off (PTO)
• approximately 18 paid company holidays per year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal