What are the responsibilities and job description for the Validation Engineer (Medical Device) position at Scalable Systems?
Job Role – Validation Engineer (Medical Device)
Location – San Diego, CA (Day 1 Onsite)
Role Descriptions: 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 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
Role Overview:
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:
o Protocol authoring
o Test execution
o Documentation and reporting
o 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
Generic Managerial Skills, If any
1. Leadership
2. Communication Skills
3. Stakeholder Management
4. Decision Making
5. Problem Solving
6. Mentoring & Coaching
7. Conflict Resolution
8. Strategic Thinking
9. Time & Priority Management
10. Adaptability & Flexibility
Desirable Skills:
Keyword:
Skills: ISO 13485~EIS : Medical Device & Regulations Experience Required: 10 & Above
Salary : $35 - $40