?? ?????? ?????? – ???????? ????? ?????: Mechanical Engineer – Medical Device R&D; / Sustaining Engineering

????????: Coimbatore / Hyderabad

??? ???????We are looking for an experienced Mechanical Engineer to drive the design, development, verification, validation, and sustaining engineering of innovative medical device products. The role involves collaborating with cross-functional teams including Systems, Electrical, Software, Quality, Regulatory, Manufacturing, and Supplier Engineering throughout the product lifecycle.

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- Develop and maintain mechanical designs for medical device products and subsystems
- Translate product and system requirements into mechanical design specifications
- Create and review 3D CAD models, assemblies, and engineering drawings
- Perform GD&T;, tolerance stack-up, and tolerance analysis
- Conduct mechanical design analysis including structural, strength, and material evaluation
- Select appropriate plastics, metals, and other medical-grade materials
- Design components considering DFM, DFA, manufacturability, reliability, and cost
- Support prototyping, engineering builds, and design iterations
- Plan and execute Design Verification & Validation (V&V;) activities
- Prepare test protocols, engineering reports, and technical documentation
- Participate in design reviews, DFMEA, risk analysis, and risk mitigation activities
- Investigate product failures, NCRs, CAPAs, and field issues using root cause analysis
- Support engineering changes,



sustaining engineering, supplier development, and design transfer
- Maintain Design History File (DHF) documentation and ensure compliance with medical device standards

??????????????
- 5–6 years (Senior Engineer), 8–10 years (Lead Engineer), or 10+ years (Principal/SME)
- Bachelor's degree in Mechanical or Biomedical Engineering
- Robust experience with SolidWorks, Creo, or equivalent CAD software
- Expertise in GD&T;, tolerance analysis, and engineering drawings
- Hands-on experience with plastics, metals, injection molding, machining, and precision manufacturing
- Experience in DFM, DFA, prototyping, and product development
- Knowledge of mechanical testing, V&V;, FMEA, Design Controls, and DHF documentation
- Experience in medical device product development is highly preferred

????????? ??????
- ISO 14971 Risk Management
- ISO 13485 Quality Management Systems
- FDA Design Controls
- IEC 60601 Medical Electrical Device Standards
- Minitab or statistical analysis tools
- Supplier management and design transfer experience
- Technical leadership and mentoring for senior-level candidates

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- SolidWorks / Creo
- GD&T;
- Tolerance Analysis
- DFM / DFA
- DFMEA
- Design Verification & Validation (V&V;)
- Root Cause Analysis
- DHF Documentation
- ISO 14971
- ISO 13485

?????Email: [email protected] Subject Line: Application for Mechanical Engineer

Note: Preferred Immediate Joiners(Mandtory)

📌 Mechanical Engineer – Medical Device Research And Development And Sustaining Engineering (Coimbatore)
🏢 NovintiX
📍 Coimbatore