Medical devices Software Test automation archetect

Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.

With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.

Job Description

Experience: 15+

Qualiffication:Btech/Mtech Electonics Engg

Developing Test startegy, Identifying infrastructure needs and planning resources and tools as per IEC requirements and Design controls 21CFR820

Hands-on Experience with FDA regulated (IEC 62304) Software Test Development required,
IEC 61010 ISO 14971 risk management to medical devices, ISO 13485 quality management system, and Expert knowledge of FDA regulations strongly preferred.
Building and reviewing of UL/ETL related test documentation as per IEC requirements.
Extensive experience in managing agile scrum teams and working with geographically distributed scrum teams.
Experience in working and overseeing automation of wide range and across all classes of of medical devices.
Excellent knowledge of test concepts & methodologies
Strong knowledge of test management tools like HP quality centre, JIRA etc
Expertize in usage of any of the PLM: Agile/Windchill/Quality tool
Atleast last 7 years experience in Medical devices
Secondary skills:
Experience in participating in complete life cycle starting from business analysis through testing
Experience in working on tools used in CICD environment will be an added advantage.
Required Expereince to demonstrate:
o Ability in creating test strategies and test plans.
o Capabilities in estimating work, meeting quality and timeline expectations.
o Facilitate software releases while working closely with development, systems, and support teams.
o Mentor and/or provide training to less experienced peers.
o Experience with FDA regulated (IEC 62304) Software Test Development, 1SO 14971 risk management to medical devices, ISO 13485 quality management system, and Expert knowledge of FDA regulations strongly preferred.
o Skilled in cross-functional top-down and bottoms-up risk analysis
o Experience in FMEAs for multiple disciplines: electrical, mechanical and software
Desired:
o Extensive experience in usage of automated test tools such as Jenkins, Selenium etc
o Exposure in Test Framework designing / automation testing
o Excellent communication skills to engage and energize cross-functional teams
o Ability to comprehend complex problems and good problem-solving skills
o Experience in Agile / Scrum

Skills & Experience

Cyient is an Equal Opportunity Employer.

Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.