Senior Technical Architect – Medical Devices

Key Responsibilities

• compliance
• device architecture
• risk analysis
• prototype
• bom management
• v&v testing

Tasks

-Design for compliance with regulatory standards -Develop Medical device architecture (Mechanical) -DFMEA, PFMEA and SFMEA document preparation and control -Support for maintenance of Design History file, Device History Record and Device Master Record documents -Prototype development and supplier management and detailed DFM reviews. -Manage complete system Bill of materials. -Support for Pilot lot assembly & production support -Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting. -Document and change management process in medical device industry using PDM/PLM software. -Support for Verification and Validation tests (External and Internal) -Design documentation, review critical designs and release for Prototype/Production

Requirements

• solidworks
• creo
• gd&t
• fea
• iso 13485
• medical devices

What You Bring

-Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing. -Labelling and Packaging design experience -Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support) -Good Customer from ending, Delivery Leadership experience as Tech Architect, good Team player, Team management skills. -Ability to take initiatives and drive the project to completion. -Expertise in Change Management process. -Experience in Obsolescence management. -Work experience with Mechanical part development/tool design, CAD drawings & Manufacturing Drawing -Material selection proficiency. Assess impact of alternate material and finalization with Supplier. -Good mechanical design skills with GD&T and tolerance stack up, FEA and CFD knowledge -Good knowledge on manufacturing processes- DFM, DFA, DFT -Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR -Knowledge on Quality Management System as per ISO 13485 -Mechanical Design Engineer with 15-20 Years of experience -Minimum 8 years’ experience in medical devices, Renal dialysis machines and consumables design. -Proficiency in Plastic, Sheetmetal and machined part design -Risk management documentation as per ISO 14971 -Proficiency in 3D tools like Solid works, Creo, etc. -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 -Experience in Sustenance activities in medical products/ Healthcare business

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