Senior V&V Engineer - Medical Devices (Regulated Testing)

PineQ Lab Technology; Milpitas (CA); Presencial; USD 100 000 - 140 000; Tempo integral

Resumo da oferta

PineQ Lab Technology is seeking a senior Verification & Validation (V&V) Engineer for the medical device sector. The role focuses on protocol development, execution, and generating comprehensive reports, working independently in a regulated environment.

The candidate will engage in hands-on V&V activities, ensure compliance with quality processes, and collaborate across teams to meet FDA, ISO 13485, and IEC 62304 standards while contributing to product life-cycle documentation.

Qualificações

• Experience developing, executing, and reporting test protocols for medical devices in a regulated environment.
• Hands-on Verification & Validation activities with strong attention to traceability and documentation.
• Knowledge of regulated environments and quality processes (FDA, ISO 13485).
• Exposure to legacy operating systems and legacy technologies is a plus.

Responsabilidades

• Lead protocol development, execution, and reporting for V&V activities.
• Perform hands-on verification and validation in a regulated setting.
• Maintain high-quality documentation and traceability throughout products’ life cycle.
• Collaborate with cross-functional teams to ensure compliance with standards (FDA/ISO/IEC).

Conhecimentos

Protocol writing

V&V execution

Report generation

Legacy OS

Legacy tech

Regulated environments

Quality processes

Analytical skills

Communication skills

Self-motivated

Independent work

FDA knowledge

ISO 13485

IEC 62304 familiarity

Descrição da oferta de emprego

PineQ Lab Technology is seeking a senior Verification & Validation (V&V) Engineer for the medical device sector. The role focuses on protocol development, execution, and generating comprehensive reports, working independently in a regulated environment.

The candidate will engage in hands-on V&V activities, ensure compliance with quality processes, and collaborate across teams to meet FDA, ISO 13485, and IEC 62304 standards while contributing to product life-cycle documentation.