Senior Verification & Validation (V&V) Engineer

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 documentationu2011focused role, not handsu2011on test execution. Key Responsibilities u2003u2022 Support DV readiness for an existing product as part of a larger lifecycle management initiative u2003u2022 Remediate and update V&V and design control documentation u2003u2022 Update hazard analyses and risk management documentation u2003u2003u25cb Trace hazards to risk controls and verification measures u2003u2022 Complete and remediate Risk Traceability Matrices u2003u2003u25cb Ensure traceability across system, subsystem, software, and verification u2003u2022 Independently create and implement ECOs/ECRs in Agile PLM u2003u2022 Update hardware and software outputs, including: u2003u2003u25cb Releasing new software part numbers (PNs) u2003u2003u25cb Updating existing software PNs u2003u2003u25cb Generating software installation procedures u2003u2022 Update assembly procedures, particularly softwareu2011related and systemu2011level procedures u2003u2022 Collaborate with technical lead, Quality, and crossu2011functional 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 learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements Required Qualifications u2003u2022 5u20138 years of experience in Verification & Validation, Systems Engineering, or Risk Management u2003u2022 Strong systems engineering background with supporting software experience (hybrid profile) u2003u2022 Proven experience with: u2003u2003u25cb Design controls and lifecycle documentation u2003u2003u25cb Risk management and traceability u2003u2003u25cb DV readiness activities u2003u2022 Handsu2011on experience working in Agile PLM u2003u2003u25cb Ability to independently own change orders (no superu2011user level required) u2003u2022 Medical device industry experience required u2003u2022 Experience working under ISO 13485 design control frameworks u2003u2022 Comfortable working onsite 3u20134 days per week Nice to Have u2003u2022 Experience with softwareu2011related assembly or installation procedures u2003u2022 Exposure to audits, CAPAs, or postu2011market remediation u2003u2022 Prior interaction with Quality and Regulatory teams Additional Notes u2003u2022 Primary focus is documentation remediation, not test execution u2003u2022 Small, focused remediation team (3 core members) u2003u2022 Reports into technical lead u2003u2022 Headsu2011down execution with limited crossu2011functional coordination This role is not a handsu2011on testing engineer u2014 itu2019s more of a documentation and cleanu2011up role for an existing medical device product. The product already exists and is on the market, but theyu2019re doing a software update and need to make sure all of the paperwork and documentation behind the product is correct, connected, and auditu2011ready 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.

Created: 2026-04-06