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Senior Process Development Engineer

Company: Owens & Minor
Location: Alpharetta
Posted on: August 5, 2022

Job Description:

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.

Owens & Minor Teammate Benefits Include

  • Medical, dental, and vision insurance, available on first working day
  • 401(k), eligibility after 30 days of employment
  • Employee stock purchase plan
  • Tuition reimbursement
  • Development opportunities to grow your career with a global company
    Summary

    The incumbent will be responsible for design, development, and commercialization of processes and equipment for existing products and other new medical devices. They will work with project teams and leaders to create/redefine product specifications through innovative and robust processing solutions. The incumbent will also be responsible for test development, protocols and reports related to verification and validation device testing. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States.

    Core Responsibilities
    • Provide technical leadership on new medical devices, by designing and developing manufacturing processes and related fixtures and tooling that are consistent with low defect levels and low product cost.
    • Be the subject matter expert (SME) related to process development on any given project.
    • Conferring with vendors in determining product specifications and arranging equipment, parts, or material purchase, and evaluating products according to quality standards and specifications.
    • Estimating staffing requirements, production times, and relative costs to provide data for operational decisions.
    • Develop capital equipment estimates and submit appropriation requests.
    • Working closely with the local manufacturing department and contract manufacturers to develop, coordinate, and implement technical training for employees.
    • Creating and maintaining accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&E and quality assurance functions.
    • Supporting company policies and procedures, goals and objectives, FDA regulations, and goods manufacturing practices.
    • Research and purchase new manufacturing technology, work in collaboration with the local engineering department to better production equipment functionality.
    • Implement the transition of new technology to make sure production continues successfully without any delays.
    • Act as a mentor to junior engineers within the Process Development Group.
      Qualifying Experience
      • Bachelor's Degree or advanced degree in Industrial, Manufacturing, Mechanical or Electrical Engineering. Master's Degree in Engineering preferred
      • 6+ years' experience designing and developing manufacturing processes and tooling to enhance productivity and product quality
      • 10+ years' experience in new process development
      • Strong experience using manufacturing analysis tools; such as but not limited to, DOE, process capability studies, six sigma etc.
      • Familiar with writing validation protocols, execution and thereafter data analysis.
      • Performed design transfers of new products from initial concept through launch.
      • Experience with working with external service providers.
      • Knowledge of engineering & project management principles, & scientific analysis.
      • Willing to travel up to 50% of the time.
      • Experience in medical device manufacturing processes including but not limited to- injection molding, extrusion, adhesive bonding, ultrasonic bonding, die cutting, UV/Thermal adhesive dispensers, and vision systems a plus.
      • Knowledge of polymers, polymer processing techniques, and metrology
      • Green Belt in Lean Principles-Black Belt a Plus.
      • Working knowledge of solid modeling (Solid Works preferred).
        If you feel this opportunity could be the next step in your career, we encourage you to apply.

        Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

Keywords: Owens & Minor, Alpharetta , Senior Process Development Engineer, Engineering , Alpharetta, Georgia

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