V&V Lead

GAC Solutions; Massachusetts; On-site; USD 100,000 - 130,000; Full time

Job summary

GAC Solutions is seeking an experienced Verification Lead in Massachusetts to define and drive the verification strategy for medical device software and systems. This role involves leading verification planning, risk-based testing, and ensuring compliance with regulatory and quality standards.

The ideal candidate should possess 8+ years of experience in Verification or Quality Engineering, strong expertise in regulatory standards, and excellent leadership and communication skills.

Qualifications

• 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.
• Proven ability to author verification plans, test protocols, and audit-ready documentation.

Responsibilities

• Develop and maintain Verification Plans and Master V&V Plans for software and system-level verification.
• Design and execute risk-based verification activities aligned with industry standards.
• Establish requirements-to-test traceability and ensure verification of all requirements.

Skills

Verification planning

Risk management

IEC 62304

ISO 14971

ISO 13485

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Computer Science, or related field

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.