V&V Engineer

Mechanical V&V / Design / Quality Engineer with 8-10 Years of experience

Minimum 5 years\ experience in medical V&V

Writing V&V Protocols, Test Cases, and execution

Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements

Creation of various test plans and execution for black box testing (Like performance testing, end user testing, functional testing and usability testing).

Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.

Support for DFMEA, PFMEA and SFMEA document preparation

Document and change management process in medical device industry using PDM/PLM software.

Experience in Obsolescence management.

Support for creation of Design History file, Device History Record and Device Master Record documents

Co-ordination with External Compliance agencies for EMI/EMC and Safety testing

Contributing to DfM, DfA, and usability efforts

Identifying, analyzing, and driving technical issues to resolution

QMS compliance management as per ISO 13485

Support for DHF and DMR preparation

Sound Regulatory knowledge: IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral standards, etc