Senior R&D Engineer (Design Verification and Validation)
You will be engaging in design verification & validation and technical test support activities of new market-leading microscopy products. You will utilize your experience and knowledge in electronic hardware, firmware and software for developing verification and test solution. You will be working closely with R&D, production and external suppliers.
- Perform design verification & validation of new products for medical and other mission-critical systems,
- Analyze design specifications and creating verification plan with test procedure and acceptance criteria, conducting verification test and generating test report.
- Responsible for the entire design verification and validation process to ensure compliance to regulatory requirements including relevant EMI/EMC, FDA, GMP, ISO 13485 standards,
- Assume overall responsibility for ensuring the design quality of all new products designed by Leica Singapore R&D reached the required standard before transfer to production,
- Oversee the continuous improvement in the design verification and validation processes to keep pace with changes in the regulatory environment,
- Comply and adhere to the regulatory ISO 14001, OHSAS 18001 and company 's EHS requirement.
- Masters / Bachelor degree in Mechatronics, Electrical & Electronics or Computer Engineering
- 5 years of relevant experience in design verification and validation of medical device
- In-depth knowledge of test and design verification methodologies, required documentations, and regulatory requirements
- Experience in bringing new medical device/equipment through the verification and validation process to market introduction
- Good awareness of emerging trends in the medical device regulatory environment
- Good knowledge of general and medical device/equipment regulatory standards & requirements.