Engineering Project Lead

Responsibilities:

Lead, plan, and coordinate end-to-end cross-functional activities of products in sustain and NPI phases.

Develop a detailed project plan that is both holistic and detailed, considering design control deliverables (all technical aspects) and other deliverables required for a clinical study or commercial/regulatory launch.

Schedule regular project status update meetings and reviews with a cross-functional project team. Ensure the completion of project activities and deliverables according to the project plan.

Responsible for product integration, reliability, qualification, environmental, and safety tests in external labs and in-house. Support products DHF & DMR lifecycle processes.

Provide 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 Service, Clinical, QA, RA, Operation, and BD departments on service calls, CC, CAPA, waivers, regulatory submissions, and others.

Initiate and lead design reviews at required stages of the project process.

Manage local and overseas subcontractors with availability to travel abroad and domestically.

Requirements:

Bachelor’s degree in mechanical engineering with project management experience in a medical multidisciplinary technology company or equivalent.

2-5 years of experience in medical device development, including medical multidisciplinary capital equipment and disposable units.

Excellent knowledge of R&D, engineering, program management, and planning processes, as well as experience in the medical device product lifecycle.

Demonstrated experience in product releases throughout the entire NPI cycle. Proven execution skills in meeting project goals with desired quality, performance, schedule, and budget.

Demonstrated problem-solving ability and results orientation.

Familiarity with ISO13485, FDA, NMPA, PMDA, and other regulatory standards.

Proficiency in MS Office, MS Project, and MS Planner is a must.

Experience in SolidWorks, LabView, and Imaging software is an advantage.