System V&V Engineer

PhilipsMalvern, PA
Hybrid

About The Position

The Systems V&V Engineer is responsible for contributing to high-quality system verification and validation activities by supporting the execution of the overall system-level Verification & Validation (V&V) strategy. This role focuses on planning and executing system-level test activities to ensure integrated systems meet user, clinical, business, and regulatory requirements, under the guidance of more senior technical leaders.

Requirements

  • 3+ years of relevant experience in systems testing, verification & validation, or a related engineering role.
  • Medical device industry experience preferred.
  • Hands-on experience executing system-level or integration test activities for complex products.
  • Experience with requirements management.
  • Experience with digital traceability tools and test automation is a plus.
  • Skills include medical device standards and regulations, such as ISO 14971, IEC 62304, IEC 62366, FDA GMP/QSR, and knowledge of their impact on verification and validation.
  • Ability to manage assigned tasks, follow defined processes, and collaborate effectively within cross-functional teams.
  • Bachelor's Degree required.
  • Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • Communicate clearly and effectively, with solid analytical and problem-solving skills related to system test and verification.

Nice To Haves

  • Master's Degree preferred in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science Engineering or equivalent.

Responsibilities

  • Contribute to the execution of system-level Verification & Validation (V&V) activities across the product lifecycle to ensure quality and regulatory compliance.
  • Support development and maintenance of system-level V&V plans, test protocols, and acceptance criteria, aligned with the overall system test strategy.
  • Translate user needs and system requirements into system-level verification and validation test cases with appropriate traceability.
  • Execute and document system integration, verification, and validation testing, covering hardware, software, subsystems, and external interfaces.
  • Analyze test results, identify issues and risks, and collaborate with cross-functional teams to support timely resolution.
  • Participate in system test, technical, and design reviews with focus on verification coverage, defects, and readiness milestones.
  • Support Product Safety Risk Management activities by verifying implementation and effectiveness of assigned risk controls in a regulation-compliant manner.
  • Apply standard test practices, tools, and templates, and contribute to continuous improvement of system test processes.

Benefits

  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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