Verification & Validation Engineer - Embedded Systems
1 month ago
V&V Engineer
Job Overview :
As a V&V Engineer, you will be responsible for performing unit testing, integration testing, and verification and validation (V&V) processes for medical devices. This role requires collaboration with the design team to troubleshoot, debug, and perform root cause analysis on hardware and firmware issues. You will also be involved in developing and maintaining verification test plans while ensuring compliance with regulatory standards such as US FDA and EU MDR.
Key Responsibilities :
- Perform unit testing, integration testing, and pilot unit V&V.
- Conduct thorough requirements analysis.
- Familiarity with US FDA and EU MDR (IQ/OQ/PQ) V&V guidelines.
- Create and maintain verification test plans and documentation.
- Collaborate with design teams to debug issues and identify root causes.
- Perform firmware verification in compliance with IEC 62304 standards.
- Execute component-level and system-level validation.
Preferred Skills :
- Experience in verification and validation activities, including test planning.
- Proficiency in using test management tools (i.e., JIRA).
- Hands-on experience with Process Validation, Tools/Jigs/Fixtures Validation, and Equipment Validation.
- Experience with process automation and execution.
- Ability to interpret PCB schematics and familiarity with tools like Eagle, Altium, and Arduino.
- Knowledge of Embedded C, C++, and automation toolkits.
- Proficiency in Excel, Word, JIRA, and Notion is highly desirable.
- Strong analytical thinking and problem-solving skills.
- Excellent oral and written communication skills.
Expected Candidate Profile :
- Minimum 3 years of experience in the verification and validation of medical devices.
- Expertise in the design and development of electronic hardware and embedded systems.
- Experience in debugging and testing of hardware.
- Prior experience in documentation and technical writing
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