07/05 Sunilkumar Shilpi
Talent Acquisition at Tata Elxsi

Views:163 Applications:11 Rec. Actions:Recruiter Actions:2

Tata Elxsi - Verification Lead/Senior Engineer - DOORS/Jira (5-8 yrs)

Pune Job Code: 441041

Qualification : Bachelor's Degree in Electrical Engineering or Computer Science, Bio-Medical.

Experience : 6-8 years of relevant experience in Verification with minimum 3+ years of experience with Medical Device industry

Responsibilities :

1. Conduct Product functionality analysis based on product requirements

2. Executes, performs, summarizes, reports out verification & validation test activities of component / Sub-system

3. Responsible for independently Planning, Verifying and Validating the device with minimal / no supervision

4. Work closely with cross-functional teams in all aspects of device testing and test framework V&V work - specification development, material testing, Functional testing

5. Document Test Plans, Test Procedures based on functional and usability requirements

6. Document Installation/Operational/Performance Qualification Protocols

7. Participates in the development of Verification & Validation methodologies in accordance with applicable medical standards.

8. Supports the qualification of verification lab, productivity improvement efforts, including testing, building fixtures, calibration and data collection.

9. Hands-on with oscilloscope, function generator, DMM and other Lab measurement instruments

10. Establish test, verification guidelines and framework required for verification

11. Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.

12. Identifies the defect, reports and verifies in defect management tool following defined process.

13. Ensures Implementation of the outcome from Verification /Validation into the system and ensures compliance.

14. Prepares an MIS to the extent that Regulatory/Safety/RM Issues are covered.

Skills and Expertise :

1. Experience in medical device or product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems.

2. An understanding of test methods and processes as well as the methods used to verify product in the context of software, mechanical, electrical, functional and environmental testing environments.

3. Relevant technical testing/reliability experience in electro-mechanical, electrical testing.

4. Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problem-solving skills

5. Knowledge of IEC 60601-1-1, 1-2 standards FDA guidelines

Desired :

1. Exposure to automation tool.

2. Deep domain knowledge in design verification and validation of medical devices- Class I and II.

3. Experience with DOORS/JIRA/Requirement management tool. Bug tracking tools.

4. Experience of working or interacting with CROs

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