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Xcellance Medical Technologies Pvt Ltd
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Process and Documentation Engineer

Process and Documentation Engineer

Xcellance Medical Technologies Pvt Ltd

3 - 7 years

3 - 4 Lacs

Navi Mumbai

Posted:2 weeks ago| Platform:

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Skills Required

FMEA ISO 14971 Six Sigma ISO 13485 IEC 60601 Risk Management practices. DFMEA PFMEA IEC 62366

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Work from Office

Job Type

Full Time

Job Description

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

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Xcellance Medical Technologies Pvt Ltd

www.xcellance.com

Medical Devices

Bangalore

50-100 Employees

6 Jobs

Key People

Dr. Anil Kumar

CEO
Meghan Sharma

Chief Technology Officer
Ravi Mehta

Chief Operating Officer

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Process and Documentation Engineer

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Process and Documentation Engineer

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