Mechanical Architect – Medical Devices

Quest Global

14 years

0 Lacs

Bengaluru Karnataka India

Posted:1 week ago| Platform:

Apply

Skills Required

design support architecture engineering manufacturing compliance mdr troubleshooting risk management documentation dfmea plm software prototype development dfm maintenance verification gd&t stack packaging prototyping testing cad drawing test healthcare drive scheduling planning technology

Work Mode

On-site

Job Type

Full Time

Job Description

Job Requirements Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 14+ Years of experience Minimum 8 years’ experience in the medical device industry Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support) Develop Mechanical architecture for medical devices Proficiency in Plastic, Sheetmetal and machined part design Part, sub-system and product level concept Design, Complete Engineering design Good knowledge of manufacturing processes 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, etc. Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting. 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 and document support 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 Experience in leading a team in NPD/ Sustenance projects Proficiency in 3D tools like Solid works, Creo, etc. Proficiency in GD&T and tolerance stack up Good experience in packaging & label design as per ISTA/equivalent standards Prototyping, testing & product validation for medical devices Material 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 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 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. Show more Show less