Post Market Surveillance Engineer

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.

Post Market Surveillance Engineer

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.

• Provides information on mid-complexity product-specific concerns, responds to moderate questions from complaint evaluators and complaint 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 and pinpoints areas for business process improvements to streamline operations and enhance customer satisfaction.
• Works under limited supervision and broad guidelines and resolves complex complaints, evaluates initial assessments of reportability, promptly escalates to the manager for further determination and necessary action and 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, and 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, and maintains compliance with relevant standards.

• Bachelor's/ Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• 2+ years of experience in areas such as Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent with Bachelor’s degree.
• We prefer 3+ years of experience in medical device, Post Market Surveillance, Vigilance Reporting.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

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

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location,…