Medical Device Validation Engineer

Role - Medical Device Validation Engineer

Location - San Diego, CA (Onsite)

Exp need - 10+ years

Job Description

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: o 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

Roles & Responsibilities

• We are looking for experienced Validation & Verification (V&V) experts to support protocol development and execution for the Elita system.
• The role requires independent ownership of end-to-end V&V activities with minimal onboarding or training.
• The candidate will contribute toward executing approximately 150-170 validation protocols within a defined timeline

Key Responsibilities:

• Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.)
• Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21 CFR Part 820)
• Drive end-to-end protocol lifecycle, including:
  • Protocol authoring
  • Test execution
  • Documentation and reporting
  • Defect tracking and resolution
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory)
• Provide SME-level inputs for validation strategy and risk-based validation approaches
• Support audit readiness and documentation for regulatory inspections
• Work in a high-paced environment with immediate delivery expectations

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.