Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.

Position Title: Engineering Change & Document Control Specialist (Medical Devices)
Experience: 5–10 Years
Location: India - Remote
Work Hours: US Shift Hours

Job Summary

We are seeking an experienced Engineering Change & Document Control Specialist with a strong background in the medical device industry. The ideal candidate will bring hands-on expertise in managing Engineering Change Orders (ECOs), design documentation, and capital equipment change processes, while ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Manage and process ECOs and change requests in line with quality and regulatory requirements.
• Maintain and control design and technical documentation (drawings, specs, BOMs, DHF, DMR, etc.).
• Coordinate change approvals and implementations with Engineering, Quality, Manufacturing, and Supply Chain teams.
• Handle POs and change orders for capital equipment, including tracking, vendor coordination, and documentation.
• Ensure proper version control, traceability, and audit readiness of all records.
• Support internal and external audits related to document control and change management.
• Collaborate with global teams with at least 6 hours overlap with US EST.

Required Qualifications

• 5–10 years of experience in medical device engineering/operations.
• Strong hands-on experience with ECOs, document control, and change management.
• Experience handling capital equipment change orders and POs.
• Solid knowledge of FDA QSR, ISO 13485, and change control best practices.
• Proficiency with PLM/EDMS systems (Windchill, Agile, Arena, or similar).
• Excellent documentation, coordination, and communication skills.

Preferred Skills

• Experience supporting product development or manufacturing changes.
• Familiarity with DHF/DMR, risk management, and design control requirements.
• Ability to work independently with global cross-functional teams.

All your information will be kept confidential according to EEO guidelines.