About this role
Job Requirements
- Minimum 3-5 years’ experience in medical device industry
· Hands-on experience in all phases of medical device life cycle (NPD, sustenance)
· Proficiency in Plastic, Sheetmetal and machined part design
- 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
- Good knowledge of manufacturing processes
- Material selection proficiency. Assess the impact of alternate material and finalization with Supplier.
· 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, etc.
· 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.
· 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
- Labelling and Packaging design experience
Work Experience
- Mechanical Design Engineer with 6-10 Years of experience
- Minimum 3-5 years’ experience in medical device industry
· Hands-on experience in all phases of medical device life cycle (NPD, sustenance)
· Proficiency in Plastic, Sheetmetal and machined part design
- 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
- Good knowledge of manufacturing processes
- Material selection proficiency. Assess the impact of alternate material and finalization with Supplier.
· 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, etc.
· 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.
· 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
- Labelling and Packaging design experience