Mechanical Engineer

<strong>Job Requirements </strong><br><p style="text-align:justify;"> </p><ul><li style="text-align:justify;">Minimum 3-5 years’ experience in medical device industry</li></ul><p style="text-align:justify;"><span style="color:#121212;">·         Hands-on experience in all phases of medical device life cycle (NPD, sustenance)</span></p><p style="text-align:justify;">·         <span style="color:#121212;">Proficiency in Plastic, Sheetmetal and machined part design</span></p><ul><li style="text-align:justify;">Proficiency in 3D tools like Solid works, Creo, etc.</li><li style="text-align:justify;">Concept Design and Complete Engineering design</li><li style="text-align:justify;">Good mechanical design skills with GD&T and tolerance stack up</li><li style="text-align:justify;">Good knowledge of manufacturing processes</li><li style="text-align:justify;">Material selection proficiency. Assess the impact of alternate material and finalization with Supplier.</li></ul><p style="text-align:justify;">·         Design for compliance with regulatory standards</p><p style="text-align:justify;">·         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.</p><p style="text-align:justify;">·         Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.</p><p style="text-align:justify;">·         Knowledge on Quality Management System as per ISO 13485</p><p style="text-align:justify;">·         Risk management documentation as per ISO 14971</p><p style="text-align:justify;">·         DFMEA, PFMEA and SFMEA document preparation and control</p><p style="text-align:justify;">·         Document and change management process in medical device industry using PDM/PLM software.</p><p style="text-align:justify;">·         Experience in Obsolescence management.</p><p style="text-align:justify;">·         Manage complete system Bill of materials.</p><p style="text-align:justify;">·         Prototype development and supplier management and detailed DFM reviews.</p><p style="text-align:justify;">·         Support for Pilot lot assembly & production support</p><p style="text-align:justify;">·         Support for maintenance of Design History file, Device History Record and Device Master Record documents</p><ul><li style="text-align:justify;">Labelling and Packaging design experience</li></ul><br><br><strong>Work Experience </strong><br><ul><li style="text-align:justify;">Mechanical Design Engineer with 6-10 Years of experience</li><li style="text-align:justify;">Minimum 3-5 years’ experience in medical device industry</li></ul><p style="text-align:justify;"><span style="color:#121212;">·         Hands-on experience in all phases of medical device life cycle (NPD, sustenance)</span></p><p style="text-align:justify;">·         <span style="color:#121212;">Proficiency in Plastic, Sheetmetal and machined part design</span></p><ul><li style="text-align:justify;">Proficiency in 3D tools like Solid works, Creo, etc.</li><li style="text-align:justify;">Concept Design and Complete Engineering design</li><li style="text-align:justify;">Good mechanical design skills with GD&T and tolerance stack up</li><li style="text-align:justify;">Good knowledge of manufacturing processes</li><li style="text-align:justify;">Material selection proficiency. Assess the impact of alternate material and finalization with Supplier.</li></ul><p style="text-align:justify;">·         Design for compliance with regulatory standards</p><p style="text-align:justify;">·         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.</p><p style="text-align:justify;">·         Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.</p><p style="text-align:justify;">·         Knowledge on Quality Management System as per ISO 13485</p><p style="text-align:justify;">·         Risk management documentation as per ISO 14971</p><p style="text-align:justify;">·         DFMEA, PFMEA and SFMEA document preparation and control</p><p style="text-align:justify;">·         Document and change management process in medical device industry using PDM/PLM software.</p><p style="text-align:justify;">·         Experience in Obsolescence management.</p><p style="text-align:justify;">·         Manage complete system Bill of materials.</p><p style="text-align:justify;">·         Prototype development and supplier management and detailed DFM reviews.</p><p style="text-align:justify;">·         Support for Pilot lot assembly & production support</p><p style="text-align:justify;">·         Support for maintenance of Design History file, Device History Record and Device Master Record documents</p><ul><li style="text-align:justify;">Labelling and Packaging design experience</li></ul><br><br>