Roles & Responsibilities
· Lead, Plan & Coordinate end-to-end cross-functional activities of products in sustain & NPI phase.
· Develop a detailed project plan that is both holistic and detailed and considers design control deliverables (all technical aspects) and other deliverables
required for a clinical study or commercialregulatory launch.
· Take responsibility for scheduling regular project status update meetings and reviews with a cross-functional project team. Provide completion of
project activities and project deliverables in according to the project plan.
· Responsible for product integration, reliability, qualification, environmental, and safety tests in external LAB and in-house. Support products DHF &
DMR lifecycle processes.
· Cross-functional project execution leadership, including concept discussion, System design, Design & Technical meetings, V&V and qualification
tests, program execution, clinical and pilot trials, and product field delivery
· Provide services to ServiceClinicaQARAOperationBD departments on Service calls, CC, CAPA, Wavers, regulatory submissions and others.
· Initiate and lead the design reviews at required stages of the project process.
· Manage local & overseas subcontractors with availability to travel abroad and domestically.
Job Requirements:
· Bachelor’s Degree within appropriate Mechanical/Biomedical/System discipline with Project Management experience in a medical multidisciplinary
technology company or equivalent.
· Experience at least 3-7 years in medical device with development medical multidisciplinary capital equipment and disposable units
· Strategic planner and thinker
· Excellent knowledge in R&D, engineering, program management and planning processes having experience with the Medical Device product lifecycle
· Demonstrated experience on product releases throughout the entire NPI cycle. Proven execution skills at meeting project goals with desired quality,
performance, schedule & budget
· Strong written and oral communication skills
· Demonstrated problem solving ability and results orientation
· Familiarity with ISO13485, FDA, NMPA, PMDA other regulatory standards
· Experience in MS-Office, MS-Project, MS Planner – Must
· Experience in Solidworks, LabView, Imaging SW – Advantage
