Verification Engineer

5 days ago


Jurong East, Singapore Leica Microsystems Full time

Leica Microsystems has helped shape the future of microscopy for over 170 years by developing groundbreaking optical and digital solutions.
As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people.
Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.
Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our
commitment for brilliant solutions and insight.
Leica Microsystems is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the
future of science and medicine, developing products that enable researchers in the fight to save lives.

**GENERAL SUMMARY & OVERALL CHALLENGES**
- Contribute and support design verification tasks such as automated testing and technical test support activities of new market-leading microscopy products.
- Utilized personal experience and knowledge in mechanical, electronic hardware, firmware, and software for developing verification and test solution.
- Design and develop test firmware/software to realize new solutions with assuming overall responsibility for the delivery and quality of the new solutions
- Provide support for analysis and countermeasures for field returns
- Cultivate an environment to promote innovation and ensure a strong IP pipeline.
- Comply and adhere to the regulatory and company’s EHS requirement.
- Participate in lean and continuous improvement initiatives and projects.
- 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 fulfil standards and customers’ expectations.

**KEY RESPONSIBILITIES**
- 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 and review documents.
- Responsible for the entire design verification and validation process to ensure compliance to regulatory requirements including relevant EMI/EMC, FDA, GMP, ISO and IEC 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 company Quality Management System and Environment, Health & Safety requirements.

**REQUIREMENTS FOR THIS POSITION**

**a) Professional Experience**
- Experience in a similar position in a similar operation
- General understanding of different engineering disciplines
- Knowledge and capability in developing automated test firmware/software
- Preferred background in Medical Device Industry
- Preferred background in Applied Device Industry
- Preferred deep knowledge in Surgical Microscopy
- Interdisciplinary communication skills (customer, PM, R&D, RAQA, internal and external supplier)

**b) Education**
- Good Bachelor’s degree in Mechatronics, Electrical & Electronics or Computer Engineering with 3 years of relevant experience in design verification and validation of medical devices.

**c) Language**
- English

**d) Travel (required estimated % of time)**
- 10%

**e) Other**
- In-depth knowledge of automation 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,
- Knowledge of industrial manufacturing procedures
- Good analytical and troubleshooting 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.
- Learn all there is about Kaizen, PSP's and Muda as part of our Danaher Business System (DBS) trainings - if you believe in
- continuous improvement like us
- We have no room for prejudices and stereotypes. We promote equal opportunities, diversity and inclusion.
- We offer a balance between support and autonomy to achieve your own goals in an international environment

**GET MORE INSIGHT**
Learn more about what we do and who we are by watching our company video “We Are Leica”:
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 f



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