Verification & Validation Engineer - Medical Device

Job Description:

• Lead V&V Engineer with extensive medical device validation experience

  Possesses educational qualifications and work experience as established by engineering schools, employers and licensing authorities for employment in the various disciplines of engineering, i.e. Mechanical, Electrical, Industrial, Manufacturing, Chemical etc. Experience level: 7+ years.

   

  Job duties:

  • Read and understand customer and product requirements.
  • Work in a team environment to author V&V protocols using peer review process.
  • Design and conduct studies to validate performance characteristics of hematology products. Review and analyze performance data and create review summary of tests.
  • Conduct technical reviews of test data and create verification and validation summary documents. Provide technical leadership to junior scientists and engineers.
  • Familiarity with regulatory and ISO requirements is a plus.

   

   

Skills Required:

• 5-7 years relevant Medical Device V&V experience in an FDA-regulated.
• Extensive knowledge and experience in biological and diagnostics systems
• Customer focused; Excellent oral, written communication and interpersonal skills
• Excellent written communication skills; the ability to articulate complex technical concepts and issues in a simple, easy to understand manner.
• Must be able to interact effectively and work well with team members under stressful conditions.

• Knowledge of GMP, FDA and ISO standards