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Technical Specialist - Testing

Bengaluru, KA
Job Code:
  • Manufacturing & Production
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Job Details

Conduct Design V&V activities as an active member of project teams designing and developing medical devices. Devices are mechanical and electro-mechanical systems with embedded software intended for use by patients with sleep and respiratory disorders. OUTCOMES The successful candidate will be responsible for analyzing and verifying product requirements and designs, and testing the products at various levels to ensure that the products meet the requirements and intended use. Tasks includeAnalyzing product and sub-system requirements.Analyzing and verifying medical device designs.Writing detailed test procedures that evaluate medical devices and systems against documented mechanical, electrical and software requirements.Conducting statistical analysis of test results.Maintaining and controlling test execution records using good lab practices.Technical writing, including development of test reports.Ability to learn new technologies and gain an understanding of system architectures. BEHAVIORS The successful candidate will demonstrate the ability to work as a member of a team, solve problems, meet commitments, and ensure quality.Works with system level, multi-disciplined engineering projects.Requires limited directionAbility to analyze requirements and develop a risk based approach to testing.Communicates at all levels of the organization.Ability to work independently and in a teaming environment.Have a good problem solving methods and skills.GROWTH The successful candidate will develop relationships with teams and take on leadership roles to plan, guide, and track project efforts, and manage people. EDUCATION BS in Engineering, Computer, or other Science discipline, or equivalent. EXPERIENCE 6+ years with BS. Preferred experienceSystems engineering and testing of electrical/mechanical/software systems.Experience performing verification and validation activities in a regulated environment.Disciplined, regulated industries, medical device experience preferred, including FDAs 21 CFR 820/ISO 13485 experience.Software development using ISO 62304 or equivalent.Risk Management using IEC 14971 and IEC 60601 or equivalent.
Additional Degree: BE/ B.Tech (Engineering)

Experience: 6-11


Application Programming | Database Administration (DBA) | Software Engineer
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