General Summary
This role is pivotal in managing and overseeing the software development lifecycle, from planning to decommissioning.
Requires a deep understanding of the software Chinese regulation, including the ability to introduce the regulation requirement, monitor and control the progress of software implementations in global team.
Requires experience in embedded software project deliveries, preferred healthcare.
Capable of explaining technical solutions and outcomes to RSUZ stakeholders.
Provides detailed project information to cross-functional teams and influences and builds consensus with other software teams.
Requirements for this position
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