V&V Lead

We are seeking an experienced Verification Lead to define and drive the verification strategy for medical device software and systems, ensuring compliance with regulatory and quality standards. This role will lead verification planning, risk‑based testing, requirements traceability, protocol development, and audit‑ready documentation while collaborating closely with Engineering, Quality, and Regulatory teams.

• Develop and maintain Verification Plans and Master V&V Plans for software, subsystem, and system‑level verification.
• Design and execute risk‑based verification activities aligned with IEC 62304, ISO 14971, ISO 13485, FDA 21 CFR 820, and EU MDR requirements.
• Establish requirements‑to‑test traceability and ensure verification of all requirements and risk control measures.
• Create and review test protocols, test cases, verification reports, and compliance documentation.
• Lead technical reviews, verification activities, defect management, and design milestone assessments.
• Support regulatory submissions, FDA inspections, notified body audits, and Design History File (DHF) documentation.
• Mentor verification engineers and drive continuous improvement in verification processes, tools, and automation.

• Bachelor's degree in Engineering, Computer Science, or a related field.
• 8+ years of experience in Verification, Validation (V&V), or Quality Engineering within the medical device industry.
• Strong expertise in IEC 62304, ISO 14971, software verification, risk management, and design controls.
• Experience with connected medical devices, embedded systems, or Software as a Medical Device (SaMD).
• Proven ability to author verification plans, test protocols, and audit‑ready documentation.
• Experience supporting regulatory submissions, FDA inspections, and notified body audits.
• Strong leadership, communication, and cross‑functional collaboration skills.