We are looking for an experienced Mechanical Design Engineer with robust medical device product development expertise to drive design, compliance, and cross-functional engineering efforts for Class II & III devices.

Key Responsibilities
Strong understanding of Medical Device product development, preferably with Design Control experience for Class II & III devices (FDA 21 CFR 820.30).
Well-versed with medical device compliances, regulations & standards such as ISO 13485, 21 CFR 820, ISO 14971.
Valuable knowledge of Design Control processes, including design inputs, reviews, outputs, and change management.
Hands-on expertise in mechanical engineering design with experience in plastic injection molding, die-casting, sheet-metal forming, and machining.
Skilled in GD&T;, statistical tolerance analysis, and SPC practices.
Ability to apply DfM and DfA principles in product development.
Review, modify, and validate 3D models and 2D drawings for NPD and sustenance projects.




Familiar with Product Lifecycle Management (PLM) and tools such as Agile, Windchill, Teamcenter.
Knowledge of requirements engineering, risk analysis, and V&V; activities.
Prepare and maintain DHF documentation and ensure compliance.
Participate actively in Design Reviews across design inputs/outputs.
Work with cross-functional teams for approvals, deliverables, and PLM Change Orders.
Provide engineering support, guidance, and clear communication to internal teams.
Create regular status updates and presentations for senior leadership.

Preferred Skills & Tools
ISO 13485, 21 CFR 820, ISO 14971
CAD tools: SolidWorks, Creo, AutoCAD
PLM tools: Agile, Windchill, Teamcenter
Tools: Power BI, Minitab, Smartsheet, MS Office
Robust communication, analytical thinking, and attention to detail.

📌 Manufacturing Automation Engineer Pune
🏢 Tata Elxsi
📍 Pune