Job Requirements
Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 14+ Years of experienceMinimum 8 years’ experience in the medical device industryHands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support)Develop Mechanical architecture for medical devicesProficiency in Plastic, Sheetmetal and machined part designPart, sub-system and product level concept Design, Complete Engineering designGood knowledge of manufacturing processesDesign 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.Risk 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 and document supportDesign 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 Experience in leading a team in NPD/ Sustenance projectsProficiency in 3D tools like Solid works, Creo, etc.Proficiency in GD&T and tolerance stack upGood experience in packaging & label design as per ISTA/equivalent standardsPrototyping, testing & product validation for medical devicesMaterial selection proficiency. Assess the impact of alternate material and finalization with Supplier.Cost conscious while material & process selection

Work Experience
Work experience with Mechanical part development, CAD drawings & Manufacturing DrawingProficiency 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.Lead team effectively and work closely with customersProject scheduling and planning

Desired Skills:

Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical componentsAbility 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.