Production Engineer

Position Overview:

The Production Engineer is responsible for production project management such as yield improvement, standardization of operating principles including the work instruction update, and continuous improvement in cooperation with different departments. The role will focus efforts on developing Insulet Malaysia into a world-class manufacturing plant through a heavy emphasis on reliability engineering, standard operating procedures, result orientated, hands-on activities and operational scorecards.

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes.  Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.

Responsibilities:

• Work in production line to define and implement the improvement plan across the entire production process
• Conduct operator and machine process review to optimize the production performance
• Conduct the material side-by-side study to evaluate the material variation against the production performance
• Review the machine-to-machine variation to define the improvement plan with maintenance engineering team
• Review the manufacturing scorecard with the production team regularly in order to determine the improvement action items
• Create or update the work instruction for production team
• Deliver training to the production team about the manufacturing process knowledge across the entire production process
• Represent the production department to follow up the verification build or engineering study
• Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions
• Follow up the production issue with the production team on a 24/7 basis in necessary
• Perform other duties as required

Minimum Requirements:

Education and Experience:

• Bachelor's degree in an engineering discipline, preference in Mechanical, Electrical, or Industrial engineering
• Minimum 3 years' experience of production engineer or process engineer
• Work experience at high-volume manufacturing line in cleanroom environment
• Data-driven decision-making and result oriented
• Multi-language fluency (English, Malay minimum)

Preferred Skills and Competencies:

• Preferred familiarity with cGMP guidelines and ISO 13485 and FDA 21 CFR 820 regulations.
• Proficiency in computer aided design and standard computer/MSOffice systems. Fundamental knowledge of ERP systems; MES is a plus
• Hands-on experience in set-up and operation of automated production equipment.
• Possess the initiative and drive for continual improvement.
• Able to fulfill job responsibilities in a fast-paced/high-volume production environment.
• Previous experience running, debugging, and/or maintaining highly automated discrete component assembly equipment is preferred.
• Previous experience with technologies such as laser welding, heat staking, ultrasonic welding, and ESD-sensitive devices preferred but not required.
• Experience in a start-up production environment is a plus.
• Experience working with Human Machine Interfaces (HMIs).
• Familiarity with manufacturing instrumentation such as optical gauging, video microscopes, micrometers, calipers, feeler gauges, dial indicators, and gauge blocks.

Physical Requirements (if applicable):

• Required to work in cleanroom (production environment) for at least 80%; Sunday on duty or night shift on duty is depending on the task in necessary