CHENNAI · FULLTIME
Sustenance Engineer
solidpro - helixa
Chennai · onsite · Posted 28d ago
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Section · 01
About this role
Job Description
*Handling Engineering Change Management (ECN/ECR) activities related to site transfer.
*Experience in Design control process
*Coordinating cross-functional teams for change implementation.
*Supporting Design History File (DHF) documentation updates.
*Ensuring compliance with ISO 13485 and ISO 14971
*Performing risk assessment and documentation as part of change control.
*Supporting verification/validation activities where required.
*Experience in independently handling engineering change projects
*Good understanding of design control and DHF documentation
*Knowledge of risk management (ISO 14971)
*Familiarity with ISO 13485 requirements
*Knowledge of IQ/OQ/PQ
*Hands on experience of CAD software( SolidWorks) (preferred)
Sourcing Channels
Preferred Experience: 6 to 10 Years
Location: Bengaluru
Sourced from foundit
Section · 02