We are accepting applications on Email, Direct Applicants can submit updated CV -

Email : Sunil Chandran <Sunil.Chandran@quest-global.com>

15 to 18 years’ experience in medical device domain (preferably in R&D dept.)

· ‘Bachelor of Engineering / Diploma’ in Mechanical / Electronics and Communications / Biomedical or equivalent

· Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)

· Proficiency in Project management and execution.

· Knowledge on Quality Management System as per ISO 13485

· System Level Understanding in medical devices preferred.

· Convert Product requirement specification to Technical Specification Requirement and further into sub-system requirement.

· Develop Medical device architecture (Mechanical/Hardware)

· 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.

· 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)

· Knowledge on Usability Engineering and Environment conscious design will be added advantage.

• · Candidate having worked in medical devices domain like C Arm, Anesthesia machines or Patient monitors is added advantage.