Senior Verification & Validation (V&V) Engineer

Insight Global Senior Verification & Validation (V&V) Engineer Marlborough, MA Apply Job Description Role Summary Senior V&V Engineer to support a lifecycle management R D project for an existing regulated product undergoing a software update. The focus is Design Verification (DV) readiness through remediation and cleanup of V&V, risk management, and design control documentation. This is a documentation‑focused role, not hands‑on test execution. Key Responsibilities

• Support DV readiness for an existing product as part of a larger lifecycle management initiative
• Remediate and update V&V and design control documentation
• Update hazard analyses and risk management documentation ○ Trace hazards to risk controls and verification measures
• Complete and remediate Risk Traceability Matrices ○ Ensure traceability across system, subsystem, software, and verification
• Independently create and implement ECOs/ECRs in Agile PLM
• Update hardware and software outputs, including: ○ Releasing new software part numbers (PNs) ○ Updating existing software PNs ○ Generating software installation procedures
• Update assembly procedures, particularly software‑related and system‑level procedures
• Collaborate with technical lead, Quality, and cross‑functional partners as needed

Compensation:

$65/hr to $72/hr. Exact compensation may vary based on several factors, including location, skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements Required Qualifications

• 5-8 years of experience in Verification & Validation, Systems Engineering, or Risk Management
• Strong systems engineering background with supporting software experience (hybrid profile)
• Proven experience with: ○ Design controls and lifecycle documentation ○ Risk management and traceability ○ DV readiness activities
• Hands‑on experience working in Agile PLM ○ Ability to independently own change orders (no super‑user level required)
• Medical device industry experience required
• Experience working under

ISO 13485

design control frameworks

• Comfortable working onsite 3-4 days per week Nice to Have
• Experience with software‑related assembly or installation procedures
• Exposure to audits, CAPAs, or post‑market remediation
• Prior interaction with Quality and Regulatory teams Additional Notes
• Primary focus is documentation remediation, not test execution
• Small, focused remediation team (3 core members)
• Reports into technical lead
• Heads‑down execution with limited cross‑functional coordination This role is not a hands‑on testing engineer — it's more of a documentation and clean‑up role for an existing medical device product.

The product already exists and is on the market, but they're doing a software update and need to make sure all of the paperwork and documentation behind the product is correct, connected, and audit‑ready before they can move into formal verification testing. The person coming in is essentially helping the team get organized and ready for verification, not run tests themselves. Active Filters Senior Verification & Validation... Marlborough, MA Clear All Apply