Verification and Validation Specialist

4 days ago


Reston, Virginia, United States Skills Alliance Full time

Job Title: Verification and Validation Engineer

Location: California (Site-based)

Industry: Medical Device

Salary: Competitive & Great Benefits

Skills Alliance is partnering with a pioneering Cardiology company to revolutionize cardiac care through cutting-edge interventions. This company is introducing groundbreaking technologies for heart failure, reshaping the landscape of a $3 billion market and enhancing patient outcomes globally.

We are interested in hearing from Verification and Validation Engineers with cardiology experience seeking a step up. If you enjoy Verification and Validation Protocols, reviewing SOPs and developing design inputs, then this role is for you.

Requirements:

  • Engineering Degree or similar discipline
  • 5 years' verification and validation experience in Active Implantable Medical Device technology
  • Biocompatibility V&V testing
  • Device experience in Class III cardiac implants, including catheter, hardware, and electrical systems

Responsibilities:

  • Expertise in design controls under 21 CFR 820.30, performance specifications, and verification and validation testing
  • Extensive experience in the Medical Device Industry, including a thorough understanding of engineering design, test, and safety standards (IEC, FDA Requirements, ISO 10993, ISO 14708, ISO 11135, and other applicable standards)
  • Ensure that the Quality System is compliant with 21 CFR 820, 803, 806, and ISO 13485
  • Experience with FDA Design Controls, Class III Implants, AIMD, and Engineering Change Management procedures for medical device development is required
  • Previous experience in a Design Assurance role, ideally covering all product development phases from conception through commercialization

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities, please contact Shakir Hossain in confidence.



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