Principal Mechanical Engineer

1. Senior Technical Architect – Medical Devices P-112120 2. Mechanical Technical Lead – Medical Devices P-112584 Experience : 18 - 25 Years Senior Mechanical Architect / Principal Mechanical Engineer – Medical Devices - Renal Care portfolio (Dialysis Machines, Dialysis Consumables) You can connect with - Email : sunil.chandran@quest-global.com 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 - Work experience with Mechanical part development/tool design, CAD drawings & Manufacturing Drawing - Good Customer from ending, Delivery Leadership experience as Tech Architect, good Team player, Team management skills. - Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing. - Expertise in Change Management process. - Experience in Sustenance activities in medical products/ Healthcare business - Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR - Ability to take initiatives and drive the project to completion. Desired Skills: - Knowledge in Product Life Cycle management and Supplier transfer activities for Mechanical components - Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions. - Proficient use of enabling technology, computer and time management skills. - Having Japanese Visa and willing to work on short term/long time onsite assignment will be added advantage. Mechanical Technical Lead – Medical Devices P-112584 - Mechanical Design Engineer with 8-12 Years of experience - Minimum 6 years’ experience in medical devices industry, Renal dialysis machines and consumables design. - Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support) - Experience in leading a team of mechanical engineers in the medical device industry, providing guidance, mentorship, and technical expertise - Excellent communication skills to effectively communicate with internal and external stakeholders, presenting technical information clearly and concisely - Experience in conducting design reviews, design verification, and validation activities to ensure compliance with regulatory requirements and industry standards - Knowledge of international regulations and standards related to medical devices, ensuring products meet global market requirements - Continuous improvement mindset, identifying opportunities to enhance design processes, reduce costs, and improve product performance - Ability to adapt to changing priorities and work in a fast-paced, dynamic environment while maintaining attention to detail and quality standards - Passion for innovation and staying updated on emerging technologies and trends in the medical device industry - Ability to collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to ensure successful product development and launch - Develop Medical device architecture (Mechanical) - Design for compliance with regulatory standards - Design Control documentation for Renal care disposables products - Risk management documentation as per ISO 14971 - DFMEA, PFMEA and SFMEA document preparation and control - Prototype development and supplier management and detailed DFM reviews. - Support for Verification and Validation tests - Proficiency in 3D tools like Solid works, Creo, etc. - Proficiency in GD&T and tolerance stack up Work Experience - Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing. - Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing. - Expertise in Change Management process. Experience in Sustenance activities in medical products/ Healthcare business. - Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR. - Ability to take initiatives and drive the project to completion. - Lead team effectively and work closely with customers. Project scheduling and planning. Desired Skills: - Experience in medical devices industry is mandatory, Renal dialysis machines and consumables design - Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical components. - Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions. - Proficient use of enabling technology, computer, and time management skills. - Strong communication skills to effectively collaborate with cross-functional teams and external stakeholders in the medical devices industry.