Responsibilities:
- Performing requirements analysis to develop overall testing strategy & individual test cases & protocols.
- Identify testing requirements & dependencies
- Work with relevant experts for generating testing Jigs and dependencies
- Performing unit testing, integration testing, and pilot unit verification and validation for all Electronic/Hardware/Embedded/Mechanical/Optical subsystems.
- Handle all V&V documentation including creating and maintain verification test plans & generating final reports.
- Work with design team to debug issues and perform root cause analysis.
- Coordinate with regulatory teams for identifying & performing 3rd party tests.
- Perform Component level validation and System level validation.
- Coordinate with clinical/applications specialists to complete clinical validation/evaluation/investigation as required.
Preferred Skills:
- Strong analytical & abstract thinking, problem solving, creativity.
- Excellent oral, written communication skills.
- Prior experience participating in various activities associated with verification & validation of medical devices.
- Usage of test management tools including JIRA and others.
- Knowledge of Process Validation, Tools/Jigs/Fixtures Validation and Equipment Validation.
- Expertise in process & test automation and control.
- Comfortable with Arduino, python, Node js, C++.
- Comfortable interpreting PCB schematics & gerbers, drawings, & PRD.
- Fluency with Excel, Word, Jira, Notion.
Expected Candidate Profile:
- Minimum 2 years work experience in verification and validation of medical devices.
- Experience with design & development of electronic hardware and embedded systems
- Expertise in debugging and testing of hardware & embedded systems.
- Prior experience in documentation and technical writing