Verification & Validation Engineer

PineQ Lab Technology; Milpitas (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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).

Skills

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

Job description

• Strong experience in protocol writing, execution, and report generation.
• Hands-on experience in Verification & Validation (V&V) activities.
• Exposure to legacy operating systems, particularly Windows 2000.
• Ability to work with legacy technologies and systems.
• Knowledge of regulated environments and quality processes.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Self-motivated and able to work with minimal supervision.
• Familiarity with FDA, ISO 13485, and IEC 62304 standards is a plus.

We are looking for a senior-level Verification & Validation (V&V) Engineer with experience in the Medical

Device industry. The ideal candidate will be responsible for protocol development, execution, and reporting while working independently in a regulated environment.