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Product Engineer

General Plant Management Manufacturing & Distribution Akron, Ohio, US
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Performance Health is seeking a Product Engineer, Medical Devices to join our team.  This position is responsible for executing the technical design and development aspects of product development for medical devices (and other selected products). In addition to New Product Development, the person in this role acts as a technical resource to the organization including but not limited to: Manufacturing, Sourcing, Global Marketing, Customer Service, QA, Regulatory, Compliance and when appropriate, directly to customers.

To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Job Duties & Responsibilities

  • Completes design and development activities in accordance with the New Product Process/Stage Gate System and FDA/ISO Design Control requirements.

     a. Leadership of or participation on product development teams (stage-gate, design control)

     b. Completion of technical aspects of the projects

          - Establish appropriate design specifications and plans

          - Develop product according to design specifications and hold design reviews to communicate progress and verification activities

         - Assist in the development of processes necessary to produce the product and transfer the design effectively to manufacturing partners

          - Ensure product specifications contain the key design and performance requirements, are

            clearly written, and comply with company/customer contract requirements

          - Lead product risk activities resulting in safe and effective products

          - Document the design, development and risk activities to comply with internal and external 

            regulatory requirements

    c. Coordinates with marketing teams to conduct in-house and external product evaluations

  • Leads the Design Change process for changes to marketed products
  • Takes initiative to explore innovation opportunities including: monitoring emerging materials, processes and technologies, and exploring new product concepts/prototypes
  •  Supports manufacturing/quality projects including but not limited to:

     a. Process Validation

     b. LEAN initiatives

     c. Root cause investigations

     d. Qualification of new raw materials

     e. Identification and resolution of problems related to current manufacturing processes and

         materials

     f. Writing/maintaining/reviewing controlled documents 

     g. Training of employees on new or modified equipment, processes, procedures and materials

  • Provides technical support/leadership for many business functions throughout the organization
  • Performs other duties as assigned

Job Qualifications

  • BS in Engineering (Mechanical, Biomedical)
  • 5+ years of medical device
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  • Manufacturing & Distribution, Akron, Ohio, United StatesRemove