Manufacturing Engineer

Job Responsibilities:

Product sustaining during mass-production:

• Provide WI & DHR training and applicable technical training to production workers/trouble shooters.
• Resolve escalated trouble shooting cases from production line to ensure ensures smooth operations on the production floor.
• Support equipment engineering team to install, verify, maintain and repair production equipment. Confirm equipment calibration result. Perform product impact analysis on abnormal equipment. Promptly addresses any observed safety concerns across all operational areas by taking appropriate corrective actions to maintain a secure working environment.
• Evaluate and update product process according to design change request or factory raised product & process change request, including impact analysis, applicable process re-validations and document updates. Perform periodical process review.
• Technical support on product/material custom clearance.

Patient Safety and Quality:

• Daily NC investigation, evaluation as MRB member, and draft rework WIs to support NC disposition in production.
• Lead technical investigation on DEFOA.
• Technical support on incoming materials failure analysis, customer complaints when needed.
• Work with quality team to fulfill QMS requirement and support internal and external audits (TUV, NMPA, FDA, etc.).
• Support CAPA horizontal analysis or lead as CAPA owner when needed.

Product Productivity Improvement:

• Applies lean manufacturing principles, employing methodologies to streamline production processes, minimize waste, optimize resource utilization, and enhance overall efficiency within the manufacturing environment.

New Product Introduction/Footprint:

• Participate in PDLM/MLD projects/MLD changes to introduce new products from design to production, or transfer products from/to another manufacturing site.

You're the right fit if:

• Bachelor's Degree or above in Mechanical Engineering, Electronics Engineering, Science, Manufacturing Engineering or equivalent. Good in English, verbally and writing.
• Minimum 3-5 years of experience in Manufacturing/Operations environment. Experience of small lot production (assembly) in active medical device, process digitization and automation, are preferred.
• Knowledge of methodology of six sigma and Lean manufacturing.
• Agility of absorbing knowledge in short time.
• Enthusiasm to deep dive in medical device manufacturing.
• Problem solving ability and ownership.
• Ability to work under multiple tasks.