Senior Medical Device Verification & Validation Engineer

Warwick Consulting Limited; Boston (MA); Híbrido; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

Warwick Consulting Limited is seeking a Senior Verification & Validation Engineer to lead design verification and validation efforts for medical devices. The role emphasizes robust verification strategy, evidence review, and remediation of documentation to ensure device safety and user needs are met.

The ideal candidate will partner with Engineering, R&D, Quality, Regulatory Affairs, and others to ensure traceability, proper design outputs, and regulatory compliance across the product lifecycle.

Qualificações

• Experience with verification strategies, test protocols, and documentation in a regulated medical device environment.
• Ability to assess evidence quality, traceability, and acceptance criteria.
• Strong written and verbal communication across cross-functional teams.

Responsabilidades

• Support verification strategy development, plans, and matrices aligned with system requirements.
• Review test evidence, protocols, and reports for completeness, accuracy, and traceability.
• Coordinate with Systems Engineering, R&D, Quality, and Regulatory Affairs to close gaps.
• Lead remediation of DHF records and ensure inspection-ready documentation.

Conhecimentos

Verification & Validation

Design controls

Technical writing

Cross-functional collaboration

Formação académica

Bachelor's degree in Engineering or Biomedical Engineering

Descrição da oferta de emprego

Warwick Consulting Limited is seeking a Senior Verification & Validation Engineer to lead design verification and validation efforts for medical devices. The role emphasizes robust verification strategy, evidence review, and remediation of documentation to ensure device safety and user needs are met.

The ideal candidate will partner with Engineering, R&D, Quality, Regulatory Affairs, and others to ensure traceability, proper design outputs, and regulatory compliance across the product lifecycle.