1 Software lifecycle Management:
Oversee the entire software development lifecycle, from planning and implementation.
Deliver input to the planning process and monitor the progress of software implementations in factory.
2 Stakeholder Engagement and Communication:
Serve as an internal consultant, explaining software update and project outcomes to Suzhou factory stakeholders.
Provide detailed functional area information to cross-functional teams through presentations and educational concepts.
3 Collaboration and Compliance:
Work closely with the global software development team to clarify Chinese software related regulation and guideline. Like:
1) Cybersecurity spec YYT1843 and Guideline for Registration technical review of medical device cyber-security.
2) Guideline for Registration technical review of medical device software.
3) GMP for Medical Devices and its appendix - independent software.
4 Project and Resource Management:
Gain agreement on new software implementations, balancing schedule, cost, quality, and requirements.
Identify risks and develop scenarios for the global software development team.
Manage and empower assigned resources between projects and programs, ensuring alignment with business strategies and goals.

Requirements for this position (“What” the candidate can do)

a) Formal Education

• Bachelor’s degree or above in computer science, software engineering, information technology, or relative discipline.

b) “Must Have” Competencies / Skills / Experience

• Solid experience (10 years+) working on Medical product development lifecycles
• Professional knowledge of project management methods and estimation techniques (resources, time, and risks).
• Experience and understanding for design input and requirements to embedded devices with respect to China regulatory landscape.

“Nice to Have” Competencies / Skills / Experience

• Experience with IVD and/or Life Science instruments is a plus.
• Familiar with China medical device cybersecurity requirement and test methods is a plus.
• Experience with Medical device and software development & design control.

c) Language

• Fluency in English both written and verbal. This is mandatory.

d) Travel (required estimated % of time)

• Travel ~5%

e) Other

• Customer-facing experience

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.