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