職位描述
Reporting to the R&D associate director, the associate essentially responsible for developing new products and the systems which will be used to produce them. He/She will design and develop medical device mechanical systems. He/She also work towards improving the efficiency and performance of existing designs, equipment, systems and products. He/She undertakes extensive research to determine whether a new product will be cost effective. This involves using CAD(solidworks) to produce technical plans and working with prototypes. The job also involves collecting and analyzing data and producing detailed reports for management. Most of the job holder’s time will be spent in the design office, but there may be some time spent communicating ideas to customers. Problem-solving skills, creativity, a good knowledge of design software and the ability to work in a team are all qualities needed for this type of work.
- Serve as technical lead/project engineer for major development projects or multiple simultaneous projects. Ensure that engineering design activities are coordinated per the development procedure.
- Work closely with electrical and software engineers, designing with system-wide perspective.
- Responsible for leading, participating in or supporting the following product development activities:
· Concept, planning, design and execution stages of major new products or product enhancements
· Risk assessment
· Prototyping/testing
· Pilot Production
· Design reviews
· Verification
· Validation
· Pre-production
4.Assist in project planning and provide technical team leadership in project execution.
5.Provide technical leadership and mentorship to the mechanical engineering team.
6.As a member of multiple cross-functional teams, create and release Product Requirements, Design Specifications and Design Descriptions for assigned projects, as required by applicable medical device standards and internal procedures.
7.Research design options and perform experiments to determine potential design feasibility.
8.Interact with global and internal design and manufacturing resources to design for manufacturability, reliability and cost-effectiveness
9.Review product documentation for accuracy including documentation intended for customer use.
10.Evaluate product non-conformances and recommend design modifications.
Work closely with RA & MA department and provide technical document, test support and dossier for CFDA registration.
