Engineering Change & Document Control Specialist (Medical Devices) at Techtrueup

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

0.0

Posted On

18 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Engineering Change Orders, Document Control, Medical Device Industry, Change Management, Design Documentation, Capital Equipment Change, Regulatory Compliance, Quality Standards, PLM Systems, EDMS Systems, Windchill, Agile, Arena, Version Control, Traceability, Audit Readiness

Industry

Human Resources Services

Description

Company Description 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. Job Description 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. Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The specialist will manage and process Engineering Change Orders (ECOs) and change requests while maintaining and controlling essential design and technical documentation such as drawings, specifications, and Bills of Materials (BOMs). This role involves coordinating change approvals across Engineering, Quality, Manufacturing, and Supply Chain teams and ensuring all records maintain proper version control and audit readiness.