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Product Engineer - Distal Extremities

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Job Type
Direct Hire
Aug 22, 2017
Job ID
Product Engineer - Distal Extremities

Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, and product maintenance.
  1. Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
  2. Recommends alterations to development and design to improve quality of products and/or procedures.
  3. Determines budgets and timelines for assigned projects.
  4. Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget. 
  5. Maintains design history file for assigned projects, adhering to design control procedures.
  6. Provides Regulatory department technical support for assigned projects as needed.
  7. Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
  8. Supports Manufacturing to provide processing improvements.
  9. Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
  10. Determines necessity of testing and initiates testing of assigned products
  11. Reports progress and status of assigned projects on a timely basis to Engineering Manager. 
  12. Regularly required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
Regularly required travel to attend trade shows and visit established accounts as well as pro Education and Experience:
BS degree in Electrical, Biomedical or Mechanical Engineering. 
A minimum of 3-5 years of relevant medical device experience is required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
? Working knowledge of anatomy from an orthopedic standpoint.
? Manufacturing process knowledge preferred.
? Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
? Project management and communication skills training preferred.
Machine, Tools, and/or Equipment Skills:
  • Working knowledge of joint anatomy.
  • Proficiency in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience preferable.
  • Manufacturing process knowledge preferred.
  • Technical knowledge in development methodologies, design, and project implementation.