Verification & Validation Engineer
Listed on 2026-06-01
-
Engineering
Systems Engineer -
IT/Tech
Systems Engineer
Verification & Validation Engineer || Milpitas, CA - Onsite ||Fulltime ||8 - 13 years of experience
Job Description
Must Have Technical/Functional Skills
Must-Have Skills
" Strong expertise in V&V for medical devices
" Hands-on experience in:
o Protocol writing (IQ, OQ, PQ, CSV, system validation)
o Validation execution and reporting
" Deep understanding of:
o FDA regulations (21 CFR Part 820)
o ISO 13485 standards
o Risk management (ISO 14971)
" Experience in regulated environments with minimal supervision
" Ability to independently manage multiple protocols simultaneously
Preferred Skills
" Experience with complex medical systems (e.g., imaging systems, surgical systems, or similar platforms like Elita)
" Exposure to software validation / computerized system validation (CSV)
" Prior experience in large-scale validation programs (100+ protocols)
" Strong documentation and audit readiness experience
" Familiarity with tools like:
o Track Wise / Veeva / ETQ (or similar QMS systems)
Experience Requirement
" 8 12+ years in V&V within the medical device industry
" Proven experience working as a Subject Matter Expert (SME)
" Prior experience working in onsite client environments in the US is a strong plus
" Expat profiles are acceptable
Candidate Profile
" Self-driven and capable of working independently with minimal guidance
" Strong ownership mindset with execution focus
" Excellent communication and stakeholder management skills
" Comfortable working under tight timelines and immediate onboarding expectation
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).