ITAC

Product Development Engineer

Hoover, AL - Onsite

Job ID: 32334
Posted: 2022-09-23
Employment Type: Direct Hire

ITAC Solutions is seeking an experienced Product Development Engineer for a Birmingham, Alabama, company. The ideal candidate will have a minimum 3 years’ experience with medical device product design and development.

 

What you’ll be doing (duties of this position):

  • Develop concept designs based on design inputs.
  • Develop product specifications, support prototype development, create and execute testing methodologies, and maintain detailed documentation to evaluate design feasibility.
  • Investigate and report on industry and non-industry technologies.
  • Submit ideas for patent filings.
  • Evaluate/investigate design changes, product complaints, and non-conformances; effectively report findings and recommendations as per corporate procedures.
  • Support project scope development.
  • Generate design inputs and outputs to support the development process.
  • Develop Design History Files and support subsequent Regulatory submissions.
  • Create design verification and validation test plans and reports.
  • Execute design verification and validation testing.
  • Generate risk analysis documentation such as Failure Mode and Effects Analysis (FMEA) for new products.
  • Design and implement new methodologies, materials, and/or processes to bring concepts to market.
  • Participate in in-vitro and in-vivo studies, including animal and human evaluations as part of the development process.
  • Interface and collaborate with Manufacturing, Quality, Regulatory, Quality, Research and Development, Sales, Marketing, Accounting, Customer Care, and outside vendors to accomplish assigned tasks.
  • Present to colleagues and customers on products, device design, and applied engineering principles.
  • Occasional travel may be necessary

 

What you’ll need to be considered (requirements):

  • Minimum of 3 years of medical device product design and development experience.
  • Proficient in MSWindows and MSOffice applications (Word, Excel, PowerPoint).
  • Proficient in CAD design software (SolidWorks) preferred.
  • Ability to interact with colleagues and customers in a professional manner.

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