Quest Global
From Quest Global's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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.
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.
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
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