工作描述:
Essential Responsibilities
- Build up V&V team & competence for Anesthesia machine development, which includes mechanical, electrical and software verification & validation.
- Develop testing/verification requirements and plans for product design on both new & existing product.
- Executes test/verification & validation procedures
- Offers suggestions to refine and automate test procedures
- Perform test plan reviews
- Prioritize and schedule testing
- Support product development teams and provide need pre-qualification and verification testing
- Support the qualification of lab area productivity improvement efforts, including testing, building fixtures, calibration and data collection.
- Provide knowledge of test equipment set-up, functional operation, and interconnect of related equipment.
- Review necessary support documentation and maintain documentation for each test in a neat and organized fashion.
- Developing reporting systems to generate collateral that documents evidence of quality development processes
Qualifications/Requirements
- At least Bachelor's Degree in Mechanical engineering, Electrical Engineering or Industrial Engineering.
- 5+ year experience in an engineering field, including 2+ years of experience as a Product or Test Engineer.
- In-depth understanding of qualification equipment, test procedures and industry requirements, such as IEC 60601-1.
- A strong management & leadership Skill for leading the V&V team & a strong interpersonal skill set, including good technical communications.
- Previous project or team leadership experience.
- 2+ years development experience with Relational Database (MS SQL Server preferred)
