Verification & Validation Engineer

Job Title:
Verification & Validation Engineer

Location:

Milpitas, CA (onsite)
Job Type: Fulltime
Salary Range: $100,000 $ 120,000 per year

Role Summary
We are seeking an experienced Verification & Validation (V&V) Engineer with strong expertise in medical device validation, regulatory compliance, and system validation activities. The ideal candidate will independently lead validation initiatives, execute validation protocols, and ensure compliance with FDA and ISO standards in regulated medical device environments.
Strong expertise in Verification & Validation (V&V) within the medical device industry
Hands-on experience in:
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
CSV (Computerized System Validation)
System validation protocol writing and execution
Strong experience in validation execution, reporting, and documentation
Deep understanding of:
FDA regulations (21 CFR Part 820)
ISO 13485 standards
Risk Management (ISO 14971)
Experience working in highly regulated environments with minimal supervision
Ability to independently manage multiple validation protocols simultaneously
Strong analytical, troubleshooting, and documentation skills
Preferred Skills

Experience with complex medical systems such as:
Imaging systems
Surgical systems
Enterprise medical platforms
Exposure to software validation and computerized system validation (CSV)
Experience supporting large-scale validation programs involving 100+ protocols
Strong audit readiness and compliance documentation experience
Familiarity with Quality Management Systems (QMS) tools such as:
Track Wise
Veeva
ETQ
Prior onsite client engagement experience in the US preferred

Roles & Responsibilities
Develop, review, and execute validation protocols including IQ, OQ, PQ, CSV, and system validation documentation
Lead validation execution activities and prepare detailed validation reports
Ensure compliance with FDA, ISO 13485, and ISO 14971 standards throughout validation processes
Support risk assessments, gap analysis, and mitigation activities for regulated systems
Collaborate with cross-functional teams including Quality, Engineering, Manufacturing, and Regulatory Affairs
Support validation lifecycle activities from planning through execution and closure
Manage multiple validation projects and timelines independently with minimal supervision
Participate in audit preparation, compliance reviews, and inspection readiness activities
Support troubleshooting, deviation management, CAPA activities, and root cause analysis
Maintain accurate validation documentation and ensure traceability of testing activities
Contribute to continuous process improvement and validation best practices
Support system upgrades, migrations, and process changes requiring validation activities

Required Qualifications
8+ years of experience in Verification & Validation within the medical device industry
Strong expertise in regulated medical device environments and compliance standards
Proven experience working as a Subject Matter Expert (SME) in V&V activities
Excellent communication, stakeholder management, and documentation skills
Ability to work independently in fast-paced environments with aggressive timelines
Candidate Profile
Self-driven professional capable of managing deliverables independently
Strong ownership mindset with execution-focused approach
Excellent interpersonal and stakeholder communication skills
Comfortable working under tight timelines and immediate onboarding expectations

Preferred Qualifications
Experience working with enterprise-scale validation programs
Exposure to software and computerized system validation
Prior experience in onsite customer-facing environments in the US
Expat profiles are acceptable

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.