Immediate Start : Senior Mechanical Architect / Principal Mechanical Engineer – Medical Devices - Ren

1. Senior Technical Architect – Medical Devices P-112120

2. Mechanical Technical Lead – Medical Devices P-112584

Must Have experience - Renal Care portfolio (Dialysis Machines, Dialysis Consumables)

Senior Technical Architect – Medical Devices P-112120

Key Responsibilities

• Mechanical Design Engineer with 15-20 Years of experience
• Minimum 8 years’ experience in medical devices, Renal dialysis machines and consumables design.
• Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)
• Develop Medical device architecture (Mechanical)
• Proficiency in Plastic, Sheetmetal and machined part design
• Design for compliance with regulatory standards
• Regulatory standards knowledge like IEC 60601-1, MDR 2017 / 745 or MDR 2017 / 746, QSR per 21 CFR Part 820, particular standards, collateral standards, FDA510K, UL, CE
• Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA / troubleshooting.
• Knowledge on Quality Management System as per ISO 13485
• Risk management documentation as per ISO 14971
• DFMEA, PFMEA and SFMEA document preparation and control
• Document and change management process in medical device industry using PDM / PLM software.
• Experience in Obsolescence management.
• Manage complete system Bill of materials.
• Should be cost conscious towards the device and should take up Value Engineering initiatives.
• Design documentation, review critical designs and release for Prototype / Production
• Prototype development and supplier management and detailed DFM reviews.
• Support for Pilot lot assembly & production support
• Support for maintenance of Design History file, Device History Record and Device Master Record documents
• Support for Verification and Validation tests (External and Internal)
• Proficiency in 3D tools like Solid works, Creo, etc.
• Concept Design and Complete Engineering design
• Good mechanical design skills with GD&T and tolerance stack up, FEA and CFD knowledge
• Good knowledge on manufacturing processes- DFM, DFA, DFT
• Material selection proficiency. Assess impact of alternate material and finalization with Supplier.
• Labelling and Packaging design experience

Work Experience

Desired Skills :

Mechanical Technical Lead – Medical Devices P-112584

Work Experience

Desired Skills :