Danaher Corporation Senior Engineer, R&D Test in Singapore, Singapore
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.
II.REQUIREMENTS FOR THIS POSITION
Masters or good Bachelor degree in Mechatronics, Electrical & Electronics or Computer Engineering with 3 to 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, and
Good knowledge of general and medical device/equipment regulatory standards & requirements.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .