V&V engineerKatalyst Healthcares and Life Sciences • Indianola, PA, United States

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V&V engineer

Katalyst Healthcares and Life Sciences • Indianola, PA, United States

[job_card.30_days_ago]

[job_preview.job_type]

[job_card.full_time]

[job_card.job_description]

Roles & 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.
Compliance Testing and Certification.
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.
nalyze 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.

Requirements:

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.

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V&V engineer • Indianola, PA, United States

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