Senior Manufacturing Engineer
Nitto Denko Asia Technical Centre Pte. Ltd.| Date Posted: 9-Sep-2020
Bachelor's / Honours
- Lead the NPI activities on behalf of the company to review and buy off the medical device production setup from contract manufacturer, especially to ensure IQ, OQ, PQ from contract manufacturer to comply ISO13485
- Setup and manage the assembly process inhouse for consumerable cartridge.
- Manage operator and technician for their routine work.
- Optimize the Cartridge and Medical device manufacturing process to meet the quality, output and the cost target.
- Participate in Risk management activities and generate PFMEA to minimize production risk to the minimum level.
- Prepare documentation work for the inhouse production line setup, WI and ensure to meet IS013485 compliance
- Support the NPI activities during product development stage by determine the new assembly process and CAPEX investment.
- Defining the Test station in manufacturing process to reduce the reject ratio at End of the Line.
- Study and review the design of Jig and fixture for assembly and perform the IQ, OQ, PQ for inhouse cartridge assembly line.
- Min 5 years of manufacturing experience in the medical device and/or consumer electronics industry.
- Bachelor's in Engineering, Electrical, Mechanical or equivalent technical degree.
- Extensive knowledge of the medical device and/or consumer electronics manufacturing process.
- Experience in supporting NPI activities, from concept development to prototyping and design/documentation release to manufacturing.
- Experience in managing contract manufacturers is preferred.
- Resourceful and hands-on experience in setting up the production line and manufacturing process.
- Automation experience is advantages for future expansion.
- Team player to coordinate with R&D, Quality , Supply Chain and CMs.
- Experience with cGMP, ISO 9001 operations is required.
- Experience with ISO 13485 operations is advantageous.
- Ability to multitask, possess good leadership and manage multiple stakeholders.
Nitto Denko Asia Technical Centre Pte. Ltd.