GENERAL SUMMARY & OVERALL CHALLENGES
Responsible for designing the verification methodology, selecting appropriate testing environments, designing verification plans, selecting verification tools, and writing up verification procedures and reports. Engaged in design verification tasks as well as technical test support activities of the new market-leading microscopy products. Utilized personal experience and knowledge in mechanical, electronic hardware, firmware, and software for developing verification and test solution. Worked closely with R&D, and cross functional departments like the Industrial Engineering, Operation, Supply Chain and Logistic Teams, to ensure the quality, reliability, and robustness of the products to fulfill standards and customer expectations.
Perform DESIGN VERIFICATION of new products for medical and other mission-critical systems.
Analyze the products and design specifications to create reliable and thorough VERIFICATION procedures to determine if the products’ functionality work as intended with all the verification results clearly documented within the official verification report.
Responsible for the entire DESIGN VERIFICATION process to ensure compliance to regulatory requirements including relevant EMI/EMC, FDA, GMP, ISO, IEC standards.
Assume overall responsibility for ensuring the design quality of all new products designed by Leica Singapore R&D has fulfilled the required standard before transferring to the Operation Team.
Oversee the continuous improvement in the DESIGN VERIFICATION processes to keep pace with changes in the regulatory environment.
REQUIREMENTS FOR THIS POSITION
a) Professional Experience
Experience in a similar position in a similar operation
General understanding of different engineering disciplines
Preferred background in Medical Device Industry
Preferred background in Applied Device Industry
Preferred deep knowledge in Surgical Microscopy
Strong interdisciplinary communication skills (customer, PM, R&D, RAQA, internal and external supplier)
Masters or good Bachelor’s degree in Mechatronics, Electrical & Electronics or Computer Engineering with 5 years of relevant experience in design verification and validation of medical devices.
In-depth knowledge of test and design verification methodologies, regulatory requirements and required documentations,
Experience in bringing new medical device/equipment through the verification and validation process to market introduction,
Knowledge of industrial manufacturing procedures,
Excellent analytical and troubleshooting skills,
A good eye for details, advance verbal, and written communication skills,
Good awareness of emerging trends in the medical device regulatory environment, and
Good knowledge of general and medical device/equipment regulatory standards & requirements.
WHAT WE OFFER
Equal pay is a given for us.
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GET MORE INSIGHT
Learn more about what we do and who we are by watching our company video “We Are Leica”: [...] you interested to discover new opportunities in an innovative, team-oriented environment? Do apply online with your complete documents (cover letter, CV, certificates). We are looking forward to your application!
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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