Validation Engineer (Medical Device)

Scalable Systems is a USA based Big Data, Analytics and Digital Transformation company focused on vertical specific innovative solutions. By providing next generation technology solutions and services, we help organizations to identify risks & opportunities, achieve operational excellence and to gain an innovative edge.

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