Job Description
<Job Responsibilities> - Conduct Die insert (to be called “Pin”) making for mass production by transferring Pin profile from the manufacturing engineer department and setting up the cutting program. Note: Pin use for produce “Mold” as a product which this “Mold” will use for IOLs making. - To set up verification method for ensuring Pin quality before mass production. - To control Pin making machine (ex. ULG) and measuring equipment (ex. NC3P) related to Pin making to be ready for use without unacceptable variation. - Verification and improving the Pin treatment method (Washing and Plasma Coating ) to ensure Pin appearance quality before mass production. - Data Analysis of all parameters Pin relatively with the quality defect of SP2 IOL with statistically. - Consider engineering improvement from transferring pin profile under QMS control. - Ensure process control has good GMP. Lead PFMEA update to prevent any mistaken control from PCP, SOP, WI. Co-training w/ process owner to transfer necessary knowledge to all employees. - Support internal and external audit/ inspection to meet GMP practice. - Comply and adhere to the Regulatory, Quality and Environment-Health-Safety requirement. - Other tasks as assigned.
Job Requirement
<Necessary Skill / Experience > - Bachelor’s degree in Mechanical Engineering, Tool & Die Engineering, Industrial Engineering, Materials Engineering, or related fields. - At least 1 year as a Design Die Engineer or Die Insert in the manufacturing industry. - Must have experience using AutoCAD (2D & 3D). - Conversational middle-high level of English. - Well-organized, analytical, and self-driven with strong communication skills. - Experience in medical devices and ISO13585, and understanding the validation approach, is an advantage.