Post Market Surveillance Engineer

Philips; United States; On-site; USD 103,000 - 143,000; Full time

Job summary

Philips is seeking a Post Market Surveillance Engineer to oversee complaint handling, coordinate with stakeholders and drive investigations. The role includes mentoring new specialists, leading teams, and ensuring regulatory vigilance reporting to improve product quality and customer satisfaction.

Candidates typically hold a Bachelor's or Master's in medical/science fields or related areas, with 2+ years in related functions; 3+ years in medical devices is preferred.

Qualifications

• Bachelor's or Master's degree in Medical Sciences, Healthcare Management, Industrial Engineering, or Supply Chain Management.
• 2+ years of experience in Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control or clinical research.
• 3+ years of experience in medical device, Post Market Surveillance or Vigilance Reporting preferred.

Responsibilities

• Oversee complaint handling processes and mentor new specialists.
• Liaise with business, market, clinical and product experts to resolve complex complaints.
• Lead investigation teams and ensure accurate vigilance reporting for regulatory submission.
• Generate periodic complaint trend reports and maintain compliant documentation.

Skills

Complaint Handling Operations

Medical Device

Quality Assurance

Quality Control

Clinical Research

Education

Bachelor's or Master's degree in Medical Sciences

Healthcare Management

Industrial Engineering

Supply Chain Management

Job description

Post Market Surveillance Engineer

Job Description:

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.

Your role:

• 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.

You're the right fit if:

• 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.

How we work together

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.

About Philips

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.

Philips Transparency Details

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, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here . At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell WA.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.