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R&D Engineer

Company: CRS
Location: Plano
Posted on: March 18, 2023

Job Description:

The R&D Engineer will translate user needs into verifiable requirements and confirm that the medical devices meet the requirements through verification and validation. -

  • Assist in gathering user needs/customer requirements
  • Develop data through engineering studies that informs new product development team about performance of the product and competitors.
  • Translate customer requirements into measurable system requirements
  • Partner with design engineers in defining product requirements such that they are verifiable
  • Assist in developing Verification and Validation Plans
  • Ensure that the medical devices meet their requirements through verifications and validations activities.
  • Leverage regulatory standards from ASTM, ASME, ISO, etc. for designing the Test Methods and Design Verification.
  • Work with design team to solve problems and utilize engineering practices and techniques for root cause and statistical analysis
  • Coordinate with internal and external partners and suppliers to procure test samples and manage various studies
  • Participate in technical review for regulatory submissions
  • Travel to other manufacturing sites as necessary to support build of product for verification and validation activities and product launch efforts -Skills for Success:
    • Bachelor's degree in Engineering (Mechanical, Biomedical or Biomechanical)
    • 2 - 3 years' experience in a medical device or highly regulated industry in an engineering/design/development environment
    • Strong knowledge of and ability to use industry standards and Federal Regulations for medical device development
    • Strong analytical problem-solving skills
    • Ability to use of statistical analysis software
    • Excellent verbal and written communication skills
    • Excellent technical writing skills
    • Understanding of design controls per FDA and MDD/MDR requirements
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Keywords: CRS, Plano , R&D Engineer, Engineering , Plano, Texas

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