About the role

Position: Senior Engineer: Verification
Qualification: Bachelor's Degree in Electrical, Electronics Engineering or Computer Science, Bio-
Medical or Relevant IT industry.
Experience: 4+ years of relevant experience in Verification with experience with Medical Device
industry, Manual testing.
Responsibilities:
1. Conduct Product functionality analysis based on product requirements of embedded and
electromechanical systems.
2. Executes, performs, summarizes, reports out verification & validation test activities of
component / Sub-system / module.
3. Responsible for independently Verifying and Validating the device with minimal / no
supervision
4. Good Team player and willing to take more proactive approach since beginning of
brainstorming till execution.
5. Develop test methods and fixtures for all development testing including verification while
collaborating with development teams or outside resources
6. Document Test Plans, Test Procedures based on functional and usability requirements
7. Document Installation/Operational/Performance Qualification Protocols
8. Participates in the development of Verification & Validation methodologies in accordance
with applicable medical standards.
9. Supports the qualification of verification lab, productivity improvement efforts, including
testing, building fixtures, calibration and data collection.
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. Maintain Traceability Document on regular basis considering Delta changes.
14. Ensures Implementation of the outcome from Verification /Validation into the system and
ensures compliance.
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 realms of; software, mechanical, electrical, functional and environmental
testing environments.
3. Relevant technical testing/reliability experience in electro-mechanical, electrical, or software
testing.
4. Demonstrated initiative and analytical thinking style, able to comprehend complex problems
and good problem-solving skills
5. Knowledge of ISO-13485, ISO 14971, IEC 62304 & IEC 60601-1,2,6,8 safety standards etc.