Firmware Verification Engineer
3 days ago
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
Development of test firmware or software for medical and other mission-critical systems
Involve in entire firmware development lifecycle including requirement engineering, architectural design, coding, testing and maintenance
Design and develop test firmware 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 fulfill standards and customers’ expectations. KEY RESPONSIBILITIES
Perform firmware VERIFICATION of new products for medical and other mission-critical systems.
**Firmware/Software - DEVELOPMENT PROCESS**: improving the firmware/software development and verification process. Establish AUTOMATED TESTING process and tools.
**PRIMARY DOCUMENTATION**: Review & revise if applicable the primary documentation of components and systems according to relevant FDA, GMP, ISO and IEC standards.
**VERIFICATION & VALIDATION**: Support planning of V&V, predetermines suitable test/measurements settings
**TECHNOLOGY AND KNOW-HOW**: Share knowledge, utilize market/ technology information to meet customer needs.
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.
REQUIREMENTS FOR THIS POSITION
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
Interdisciplinary communication skills (customer, PM, R&D, RAQA, internal and external supplier)
b) Education
Good Bachelor’s degree in Software Engineering, Electronics Engineering, Computer Engineering or Computer Science with 3 years of relevant experience in firmware/software verification and validation of medical devices.
In-depth knowledge of complex embedded software/firmware development on Linux, RTOS or embedded Windows platform
Good awareness of emerging technologies and trends in the embedded software industry
c) Other
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,
Knowledge of industrial manufacturing procedures
Good analytical and troubleshooting skills with a creative mindset.
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
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.
At Danaher, we value diversity and the existence of similarities a
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