Principal Mechanical Engineer

2 days ago

Mumbai, India Quest Global Full time

Senior Technical Architect – Medical Devices P- Mechanical Technical Lead – Medical Devices P- Experience : 18 - 25 YearsSenior Mechanical Architect / Principal Mechanical Engineer – Medical Devices - Renal Care portfolio (Dialysis Machines, Dialysis Consumables)You can connect with - Email : Have experience - Renal Care portfolio (Dialysis Machines, Dialysis Consumables)Senior Technical Architect – Medical Devices P- Key Responsibilities• Mechanical Design Engineer with 15-20 Years of experienceMinimum 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 designDesign for compliance with regulatory standardsRegulatory 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, CEProvide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.Knowledge on Quality Management System as per ISO 13485Risk management documentation as per ISO 14971DFMEA, PFMEA and SFMEA document preparation and controlDocument 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/ProductionPrototype development and supplier management and detailed DFM reviews.Support for Pilot lot assembly & production supportSupport for maintenance of Design History file, Device History Record and Device Master Record documentsSupport for Verification and Validation tests (External and Internal)Proficiency in 3D tools like Solid works, Creo, etc.Concept Design and Complete Engineering designGood mechanical design skills with GD&T and tolerance stack up, FEA and CFD knowledgeGood knowledge on manufacturing processes- DFM, DFA, DFTMaterial selection proficiency. Assess impact of alternate material and finalization with Supplier.Labelling and Packaging design experienceWork ExperienceWork experience with Mechanical part development/tool design, CAD drawings & Manufacturing DrawingGood 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 businessGood knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDRAbility to take initiatives and drive the project to completion.Desired Skills:Knowledge in Product Life Cycle management and Supplier

  • Principal Mechanical Engineer

    18 hours ago

    Mumbai, India Quest Global Full time

    Senior Technical Architect – Medical Devices P- Mechanical Technical Lead – Medical Devices P- Experience : 18 - 25 YearsSenior Mechanical Architect / Principal Mechanical Engineer – Medical Devices - Renal Care portfolio (Dialysis Machines, Dialysis Consumables)You can connect with - Email : Have experience - Renal Care portfolio (Dialysis Machines,...

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