Work with product design group, supplier, and sub-contractors in the development of tooled products, including metal castings and stampings, plastics, and rubbers.
Work with the Product Design Engineering team in USA and Supply Chain in terms of research and implementation of global sourcing products for tooled metals, plastics, and rubbers to help quote both tooling and part pricing.
Cooperate with external component suppliers, assist to directly contact suppliers to make
prototype, initial samples, and to monitor and evaluate suppliers' process and a production line and know how to optimize it to maximize output per hour and per day until the launch.
Utilize supply chain and the supplier to manage the sourced components to assure items will be available for the required development and pilot production builds.
Manage and coordinate with suppliers and internal departments to assure schedules are managed to and met.
Identify project risks and make recommendations to shorten time to production and maximize product output and quality.
Review the supplier’s design solution, ensure it can achieve the part design requirements. If supplier suggest changing the part design, confirm their suggestion, and provide the suggestion and analysis report to USA Design Team.
Review and release supplier Tool design data (2D, 3D, DFMR).
Aid in supplier for molding process verification and validations (IQ/OQ/PQ).
Professional protocol and report writing.
Work with cross function teams as required.
Aids in resolution of production process problems.
Work with cross function team to maintain compliance with ISO 13485.
Comply with required regulatory agencies, FDA, CDA, CFDA.
Carry out other duties as and when assigned by the management.
Bachelor’s degree in Tool Design and Manufacturing or Mechanical Engineering or
Minimum 5 years in tool design and development and tool structure analysis.
Tooling project management experience preferred.
Experience in medical device molding preferred.
Superb English written and oral communication skills.
Ability to read 2D and 3D part prints and models.
Working familiarity with SolidWorks or other CAD applications.
Working knowledge of lean manufacturing, 5S and ISO quality system methodology.