Post Market Surveillance Engineer

About the role

In this role you are responsible for overseeing complaint handling processes, facilitating communication between stakeholders, resolving complex complaints by liaising with business/market/clinical/product experts, mentoring and training new specialists, leading investigation teams, and ensuring accurate vigilance reporting to enhance product quality and customer satisfaction.

Responsibilities

• Provides information on mid‑complexity product‑specific concerns
• Responds to moderate questions from complaint evaluators and investigators, ensuring effective communication and support throughout the process
• Analyzes the quality of the complaint handling process
• Scrutinizes the performance of both the complaint evaluator and investigator
• Identifies bottlenecks and challenges encountered during the process
• Pinpoints areas for business process improvements to streamline operations and enhance customer satisfaction
• Works under limited supervision and broad guidelines
• Resolves complex complaints
• Evaluates initial assessments of reportability
• Promptly escalates to the manager for further determination and necessary action
• Ensures thorough analysis and resolution
• Facilitates the training and qualification process for new PMS complaint operations specialists
• Provides hands‑on assistance
• Creates and documents training materials
• Offers ongoing mentorship and feedback to cultivate their skills and confidence
• Generates periodic reports on complaint trends and metrics
• Ensures accurate and timely documentation for internal review and regulatory submission
• Maintains compliance with relevant standards

Qualifications

• Bachelor’s or Master’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent
• 2+ years of experience in Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent (with Bachelor’s degree)
• Preferred: 3+ years of experience in medical device, Post Market Surveillance, Vigilance Reporting

Benefits

• Generous PTO
• 401(k) plan (up to 7% company match)
• HSA with company contribution
• Employee stock purchase plan
• Education reimbursement
• Annual incentive bonus, sales commission, and long‑term incentive opportunities

Pay

The pay range for this position in Bothell, WA is $103,000 to $143,400 annually.

Schedule

This is an office role requiring in‑person work at least 3 days per week.