Insulet
Medical Device
ProcessEngineer
Neural analysis suggests this role is
optimal for Mid candidates.
“Process Engineer at Insulet. Skills: Process Engineering, Manufacturing Engineering, Six Sigma, Lean Manufacturing. Support and implement validation for NPI. Support and implement validation for process change”
What You'll Achieve.
Process yield improvement; HC efficiency improvement; Validation implementation; Standardization of operating procedure; Reliability engineering; Result orientated; Operational scorecards; Product quality improvement; Scrap reduction; Machine optimization; Operator competence
Industry & Context.
Problem-solving; Troubleshoot issues; Identify corrective actions; Implement corrective actions
Required to work in cleanroom (production environment) for at least 80%, Sunday on duty or night shift on duty is depending on the task
What They're Looking For.
Must Have
Bachelor’s degree in an engineering discipline, Minimum 3 years’ experience of process engineering or manufacturing engineering, Knowledge of Six Sigma, Knowledge of Lean manufacturing, Knowledge of Problem-solving, Knowledge of Statistical Analysis skills, Work experience at high-volume manufacturing line in cleanroom environment, Data-driven decision-making, Result oriented, Multi-language fluency (English, Malay minimum)
Nice to Have
Familiarity with cGMP guidelines, Familiarity with EHS, Familiarity with ISO 13485, Familiarity with FDA 21 CFR 820 regulations, Proficiency in computer aided design (CAD), Proficiency in standard computer/MSOffice systems, Fundamental knowledge of ERP MES, 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, Previous experience with technologies such as laser welding, Previous experience with technologies such as heat staking, Previous experience with technologies such as ultrasonic welding, Previous experience with technologies such as ESD-sensitive devices, Experience in a start-up production environment, Hands-on experience to Process flow and capacity review, Hands-on experience to pFMEA, Hands-on experience to Quality Control Plan, Hands-on experience to Process validation
What You'll Do.
Support and implement validation for NPI
Support and implement validation for process change
Conduct Engineering study
Conduct engineering builds
Deliver result analysis
Deliver recommendation
Conduct DMAIC for continuous improvement
Standardize and implement machine-to-machine process analysis
Optimize machine performance
Conduct certification to operator
Conduct material side-by-side study
Evaluate material variation
Create manufacturing scorecard
Review manufacturing scorecard
Create manufacturing dashboard
Review manufacturing dashboard
Create work instruction
Update work instruction
Identify corrective actions
Implement corrective actions
Follow up production issue
Perform other duties as required
How You'll Work.
Team & Collaboration
Cooperation with different departments; Work in small groups; Work in cross functional teams; Work with production team
Full Job Description
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. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! 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-machi
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