Verification and Validation Specialist
7 days ago
Location: California (Site-based)
Industry: Medical Device
Salary: Competitive & Great Benefits
We are seeking a skilled Verification and Validation Engineer to join our team at Skills Alliance. As a pioneering Cardiology company, we are dedicated to revolutionizing cardiac care through cutting-edge interventions.
The successful candidate will have experience in Verification and Validation Protocols, reviewing SOPs and developing design inputs. They will be responsible for ensuring that the Quality System is compliant with 21 CFR 820, 803, 806 and ISO 13485.
Key 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
Requirements:
- Engineering Degree or similar discipline
- 5 years' verification & 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
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 is the role for you.
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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