Senior Systems V&V Engineer

Philips•Malvern, PA

1d•Onsite

About The Position

The Senior Systems V&V Engineer is responsible for defining, owning, and executing the overall system-level Verification & Validation (V&V) strategy to ensure delivery of high‑quality, safe, and compliant products that meet user, clinical, and business requirements. This role provides technical leadership for end‑to‑end system verification across the full product lifecycle, with strong accountability for test strategy, integration verification, and regulatory compliance.

Requirements

5+ years of relevant experience in systems testing, verification & validation, or systems engineering with significant responsibility at the system or product level
Medical device industry experience strongly preferred
Experience with technical leadership in defining and executing system‑level test strategies for complex, multi‑disciplinary products
Experience with automated testing, requirements management, and digital traceability tools is strongly preferred
Knowledge of medical device standards and regulations, such as ISO 14971, IEC 62304, IEC 62366, FDA GMP/QSR, and related verification & validation expectations
Ability to manage complexity, drive results, and influence cross‑functional stakeholders in the interest of patient safety, quality, and compliance
Excellent communicator with strong analytical and problem‑solving skills
Ability to clearly articulate verification rationale, coverage, and risk‑based decisions
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Medical device industry strongly preferred
Automated testing, requirements management, and digital traceability tools is strongly preferred

Responsibilities

Overall ownership of system‑level test strategy and execution (Verification & Validation) across the full product lifecycle, ensuring quality, compliance, and fitness for intended use.
Define and maintain the System V&V Master Plan, including test approach, levels of test, environments, independence, and acceptance criteria.
Translate user needs and system requirements into comprehensive system‑level verification and validation activities, including functional, performance, usability, safety, cybersecurity, and interoperability testing.
Ensure end‑to‑end traceability between user needs, system requirements, risk controls, verification, and validation evidence.
Lead system integration testing and verification activities, ensuring proper coverage across hardware, software, subsystems, and external interfaces.
Drive testability considerations upstream into system architecture and design in close collaboration with Systems Engineering, Software, Hardware, Clinical, and Quality teams.
Lead and participate in technical, design, and phase‑gate reviews with clear focus on verification completeness, residual risks, and release readiness.
Ensure system‑level verification and validation supports Product Safety Risk Management and demonstrates effectiveness of risk controls in a regulation‑compliant manner.
Provide technical leadership and mentorship on system test practices, standards, and continuous improvement across projects and teams.
Act as a key partner in regulatory submissions, audits, and inspections by providing clear, defendable test strategies and objective evidence.