Product Performance Engineer - Remote - Flagstaff Arizona

Company: W.L. Gore & Associates
Location: Flagstaff, Arizona
Posted On: 01/20/2025

About the Role: We are seeking a Product Performance Specialist to join our team. In this role you will be responsible for executing product investigation processes for a designated product group within the Medical Products Division. We are open to qualified candidates working a hybrid schedule at any of our Gore facilities.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities:

• Execute applicable investigation processes, including engineering, clinical, imaging, explant, and histology evaluations for products within designated product category
• Investigate product complaints using root cause analysis tools, leverage Risk Management Files, and consult with clinically trained associates for events within a designated product category
• Provide oversight and project management for product investigation activities being conducted to support and complete open Product Investigation Reports
• Review results of engineering, imaging, explant, and histology evaluations and create a comprehensive report summarizing the results of the Product Evaluation
• Monitor, identify, analyze, document, and escalate trends in post-market surveillance data proactively within designated product category in a timely manner using the Corrective and Preventative Action system
• Assist trend investigations by developing an Investigation Report using root cause analysis tools for identified trends within a designated product category
• Provide oversight and project management for product investigation activities being conducted to support and complete open trend investigations
• Communicate aggregate data obtained from product evaluations to New Product Development, Product Risk Management, and Commercialized Product Teams
• Report post market surveillance data Key Performance Indicators for Management Review within a designated product category
• Stay informed of regulatory trends and other external expectations regarding product investigations
  
  Required Qualifications:
  
  • Bachelors Degree in Engineering or related BS degree and minimum 3 years experience driving and/or conducting product complaint investigations, in a regulated industry, using risk management tools to inform decision-making
  • Understanding and experience working within quality system processes and procedures
  • Strong conflict resolution skills
  • Strong oral and written communication skills
  • Demonstrated ability to communicate across an organization with multiple stakeholders
  • Ability to multi-task and manage competing project and business priorities
  • Ability to travel up to 5%
    
    Desired Qualifications:
    
    • Medical Device, Healthcare or Pharmaceutical experience strongly desired
    • Project Management experience or certification
    • Previous responsibilities in Design Assurance, Quality Assurance, Safety or Regulatory Affairs
      
      Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
      
      What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
      
      We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits
      
      We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
      
      Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
      
      Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
      
      Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
      
      Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
      
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