What are the responsibilities and job description for the Verification & Validation (V&V) Engineer, Medical Devices position at Katalyst CRO?
Katalyst HLS is seeking an experienced Verification & Validation (V&V) Engineer with strong expertise in medical device compliance and mechatronic product testing. This is an excellent opportunity to work on cutting-edge healthcare technology solutions with a global healthcare company.
Responsibilities
Testing and Validation:
Responsibilities
Testing and Validation:
- Plan and conduct functional tests and performance evaluations on hardware prototypes.
- Identify and troubleshoot issues related to hardware functionality and compatibility.
- Collaborate with software engineers to ensure hardware-software integration and compatibility.
- Document and communicate test results to improve system performance and reliability.
- Plan and execute compliance tests such as EMI/EMC, electrical safety, and environmental tests in accordance with UL, CE, and IEC 60601 standards.
- Radiopharmaceutical testing (RP testing) co-ordination and support.
- Test protocol execution as per Standards.
- Support and co-ordination for Package/Environment testing.
- Coordinate with external accredited labs for formal certification testing, pre-compliance and formal test environments.
- Prepare test setups including grounding, shielding, and wiring configurations for accurate EMI/EMC measurements.
- Witness EMI/EMC tests.
- Analyze test failures and non-compliance issues, perform root cause analysis, and support design teams with actionable feedback and debugging recommendations.
- Review regulatory standards and ensure test methods are compliant with certification protocols.
- Prepare and maintain detailed test reports, compliance logs, and documentation required for certification.
- Bachelor's degree in electrical. Electronics, Mechanical engineering or equivalent.
- Experience - 8 to 12 years.
- Hands-on experience in Mechatronic product V&V.
- Knowledge of Medical device compliance & certification testing.
- Ready to work in product testing lab or client location.