Advanced System Test Engineer
Your role:
- Actively participating in planning V&V deliverables, working on V&V documentation, review of system requirement specifications, creation of traceability matrix, implementation and review of test protocol development, execution and deviation management; and working closely with cross-functional project teams.
- Creation and execution of system V&V plans to ensure the products are verified and validated.
- Development of test methods/tools in productfunction/performancesverification.
- Maintaining a traceability matrix to ensure system requirement specifications are verified.
- Ensuring the accuracy, completeness, and compliance of product V&V deliverables in a regulated medical device industry.
- Review and advice on product design documents.
- Participate in V&V team continuous improvement in competence building, working procedure, test method and tool development.
- Coordinate testing required to support regulatory submissions.
- Provide technical support on product registration.
You're the right fit if:
- Bachelor or a'bo with 5+ years experience in product verification& validation is required.
- Abundant experience in product(system) verification/design verification, in terms of planning, execution and reporting is required
- Demonstrated knowledge and experience in System Functions& Performance/Safety/EMC/ENV&ME/Reliability testing process, with commensurate skills in managing the test is required.
- Familiarity with the standards and regulations on medical devices is required.
- Experience in SW development/testing is preferred.
- Experience in test platform automation is preferred.
- Understanding or experience in Design Validation/ Usability engineering/ Clinical research or study is preferred.
- Experience in medical device development.
- Experience in Design Controls.
- The ability to work independently, prioritize multiple tasks&projects with strong commitment to project deadlines.
- Strong sense of responsibility, goodcommunication skills,self-learning ability.
- Strong ability of analyzing, reporting and presenting.
- Excellent written and verbal English proficiency is required.
- Great work ethic with a passion for quality, Lean and business efficiency.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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