Role:
Systems Engineer – Medical Device

Location:
Remote (Working as per EST or CST)

Duration:
Long Term

Our Client is seeking a System Engineer with strong experience in medical device product development, Design Controls, requirements traceability, and Design Verification & Validation (V&V;). The ideal candidate will support product development activities while ensuring compliance with FDA regulations, ISO 13485, and internal quality standards.

Key Responsibilities
- Lead Design Controls activities for medical device products.
- Maintain traceability between user needs, design inputs, risk controls, verification, and validation.
- Collaborate with Engineering, Quality, Regulatory, and Product Development teams.
- Support Design History Files (DHF), traceability matrices, and V&V; documentation.
- Coordinate Design Verification & Validation activities.
- Prepare technical documentation, protocols,



and engineering reports.
- Support compliance, remediation, and process improvement initiatives.

Required Qualifications
- Bachelor's degree in Engineering or a related field.
- 10+ years of Systems Engineering experience in the medical device industry.
- Robust expertise in Design Controls, traceability, and Design Verification & Validation.
- Solid knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device regulations.
- Excellent communication, analytical, and problem-solving skills.

Preferred Qualifications
- Experience with ISO 14971 risk management.
- Familiarity with requirements management/traceability tools (DOORS, Jama, Polarion, etc.).
- Experience supporting remediation or compliance-driven projects.

📌 System Engineer (India)
🏢 Intellectt
📍 India