Posted:6 days ago|
Platform:
Work from Office
Full Time
JD for your reference
• Solid understanding of Medical Device product development, preferably Design Control experience with Class II and Class III medical devices. (FDA 21CFR820.30)
• Must know about medical device compliances, regulations & standards (ISO 13485, 21 CFR 820, ISO 14971).
• Good understanding of Medical Device Design Control Process, including design inputs, reviews, and change.
• Proficiency in mechanical engineering design, with demonstrated knowledge of plastic injection molding, die-casting, sheet-metal forming, and machining processes.
• Knowledge of geometric dimensioning and tolerancing method (GD&T), statistical tolerance analysis, and statistical process control (SPC).
• Demonstrated knowledge of understanding and application of Design for Manufacturing (DfM) and Design for Assembly (DfA) principles
• Strong engineering skills/knowledge in product design and various manufacturing processes.
• Review and modify mechanical design files, including both 3D models and 2D drawings for NPD & Sustenance projects.
• Knowledge of Product Lifecycle Management (PLM) and exposure to PLM tools like Agile, Windchill, Team center etc.
• Knowledge in requirement engineering, risk analysis and V&V activities.
• DHF Documentation
• Participate in Design Reviews, including reviews of design inputs and outputs.
• Collaborate with cross-functional teams for review and approval of the deliverables and associated Change Orders in PLM.
• Strong communication skills, provide guidance and technical support to cross-functional support teams.
• Prepare regular updates and presentations for senior management.
Tata Elxsi
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