Design Control Product Development Specialist

Company: W.L. Gore
Location: Flagstaff
Posted on: September 19, 2023

Job Description:

About the Role: We are looking for a Design Control Product Development Specialist to join our Quality Engineering Role Excellence team. In this role, you will closely align with the product development process. You will own the creation and maintenance of the design control quality system process, as well as measure and monitor metrics related to the effectiveness of the quality system process. You will enable consistent execution of the design control process by educating and assisting those performing the process.

This position offers multiple work arrangements: on-site at our facility in Flagstaff, Arizona, Phoenix, Arizona or Elkton, Maryland, hybrid or fully remote work allowed in most locations within the United States, depending upon the responsibilities of the role and business needs.

Responsibilities:

• Work with other functions to identify, drive, and execute complex process and procedural updates based on regulatory and standards changes, strategic projects, business priority, feedback, audits, and metrics with the goal of making quality system and product development processes compliant and more efficient and effective
• Develop educational curriculum with accompanying training content and deliver training to all associates executing design control activities throughout the product life-cycle
• Provide consultation and guidance to product teams executing the design control quality system process to enable business success and support associate engagement and development
• Set appropriate metrics and gather, analyze, and share data on execution of the design control process
• Stay up to date on current regulatory expectations and needs related to design control globally
• Represent Gore's design control process during internal and external audits
  Required Qualifications:
  
  • Bachelor's Degree in Engineering, Science, or other related field
  • Minimum of 5 years experience supporting a medical device new product development through various phases of design control as well as commercialized product design and manufacturing process changes
  • Demonstrated working knowledge of global medical device quality system regulations as well as industry standards and best practices
  • Demonstrated ability to work with cross-functional teams, encourage diverse perspectives, and work independently in support of team initiatives
  • Demonstrated ability to influence and be influenced by broad leadership, including resolution of conflict that enables collaborative solutions
  • Demonstrated ability to generate creative, simplified, scalable, and sustainable solutions with large impact that meet the intent of the applicable regulations and standards
  • Ability to plan projects (e.g., timelines, resources, costs) and adjust project plans to mitigate project risk and meet business needs
  • Ability to balance what is feasible given existing resourcing and business support versus idealized solutions when making decisions
  • Excellent written and oral communication skills
  • Ability to travel up to 5%
    Desired Qualifications:
    
    • Experience making large organizational changes (including change management experience)
    • Experience teaching, coaching, or mentoring
    • Experience with systems engineering
      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
      
      #LI-MSL
      
      Additional Information
      
      • Travel%: 5%
      • Shift: Day Job
      • Schedule: Full-time
      • Posting Date: Sep 15, 2023
        About Gore
        
        For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible - not just through our products and technologies but also through individual growth and development.

Keywords: W.L. Gore, Flagstaff , Design Control Product Development Specialist, Other , Flagstaff, Arizona