TC
Verification & Validation Engineer
Accepting applicationsTata Consultancy Services · Milpitas, CA
Full-Time Principal Sicaiaterf
Posted
2d ago
Category
Test
Experience
Principal
Country
United States
Job Description
Must Have Technical/Functional Skills
Must-Have Skills
Strong expertise in V&V for medical devices
Hands-on experience in:
Protocol writing (IQ, OQ, PQ, CSV, system validation)
Validation execution and reporting
Deep understanding of:
FDA regulations (21 CFR Part 820)
ISO 13485 standards
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:
TrackWise / 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 expectations
Salary Range: $100,000 - $120,000
TCS Employee Benefits Summary
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Qualifications: BACHELOR OF COMPUTER SCIENCE
Show more Show less
Must Have Technical/Functional Skills
Must-Have Skills
Strong expertise in V&V for medical devices
Hands-on experience in:
Protocol writing (IQ, OQ, PQ, CSV, system validation)
Validation execution and reporting
Deep understanding of:
FDA regulations (21 CFR Part 820)
ISO 13485 standards
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:
TrackWise / 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 expectations
Salary Range: $100,000 - $120,000
TCS Employee Benefits Summary
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Qualifications: BACHELOR OF COMPUTER SCIENCE
Show more Show less