Process Engineer

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview:

The Process Engineer is responsible for manufacturing process improvement such as Process yield improvement, HC efficiency improvement, validation implementation and standardization of operating procedure 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 support and implement the validation for NPI and process change

· Conduct the Engineering study and engineering builds to consolidate all process data to deliver the result analysis and recommendation

· Conduct the DMAIC for continuous improvement of product quality and scrap reduction

· Standardize and the and implement the machine-to-machine process analysis according to the product spec and machine spec to drive the machine engineering team to optimize the machine performance

· Conduct the certification to the operator to meet the TPM and competence requirement

· Conduct the material side-by-side study to evaluate the material variation against the process performance

· Review the material flow to optimize the movement and the use of MES in production line

· Create and review the manufacturing scorecard and dashboard with the production team regularly to drive continuous improvement

· Create or update the work instruction for production team

· 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 process engineering or manufacturing engineering

· Knowledge of Six Sigma / Lean manufacturing / Problem-solving and Statistical Analysis skills

· 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, EHS and ISO 13485 and FDA 21 CFR 820 regulations.

· Proficiency in computer aided design (CAD) and standard computer/MSOffice systems. Fundamental knowledge of ERP systems; MES; Spotfire; PowerBI is a plus

· Hands-on experience in set-up and operation of automated production equipment.

· 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.

· Hands-on experience to Process flow and capacity review / pFMEA / Quality Control Plan / Process validation is a plus

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