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 OverviewThe Maintenance Engineer is a critical member of the plant engineering and operationsteams. This role is responsible for reliability engineering, monitoring, and standardizing themanufacturing process, anticipating, and resolving bottlenecks to capacity, driving uniformity ofmaintenance and operations principles, identifying, and implementing cost and waste reductions, andgeneral continuous improvement of the site. The successful candidate will have strong structuredproblem-solving skills of complex component and machine interactions and be comfortable workinghands-on with automated machinery.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 Accountable to driving maintenance process improvements in support of Insulet’s primarymanufacturing objectives: Best Quality, Best Service, Best Cost. Autonomously interprets data to drive plant decision making and prioritization of reliabilityefforts. Plan, execute, and manage efficiency improvement projects. Develop and implement process controls to stabilize and sustain equipment reliability. Develop and deliver training to build the capability of the plant engineering and operationsteams as part of continuous improvement efforts. Independently maintains and publishes operating scorecard to track and trendprojects/improvements. Create and modify preventive maintenance tasks and work plans to move unplanned emergencyevents to planned maintenance events. Responsible to assign/manage the technical resources and be accountable to verify thePM is effective Maintain direct hands-on interaction with the manufacturing equipment including station set-upand troubleshooting using hand tools, measurement tools, machine documents, specialty gages,and high-speed filming equipment. Provide input and support for technology transfer and equipment design reviews. Ensure compliance with safety rules, quality policies, and employee guidelines. Maintain a cGMP compliant environment and operate within FDA guidelines. Serves as back-up Engineering Maintenance Manager. Off-shift support may be required. Perform other duties as requiredEducation And ExperienceMinimum Requirements:More than 5 years of experience working directly on automated manufacturing equipmentHands-on experience in setup and operation of automated production equipmentAdvanced proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analyticsundefinedProcess oriented and uses data to make decisions.Demonstrated success using problem solving methodologies such as A3, PDCA, DMAIC, etc.Ability to fulfill job responsibilities in a fast-paced/high-volume production environment.Preferred Skills And Competencies Experience with SOLIDWORKS or AutoCAD. Hands-on technical ability with assembly methodologies including locational methods, assemblysetup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc. Mechanical aptitude, technical ability, ability to read and understand technical drawings andmanuals. Technical knowledge of cam driven linkages, discrete component assembly, and automation Familiarity with machine user interfaces (HMIs / GUIs) Familiarity working within cGMP guidelines and ISO 13485/21FDA820 regulations. Experience working in a regulated industry, in particular consumable products. Have strong interpersonal and communication skills. Excellent attention to detail, organizational skills, and rigorous process discipline Thirst for knowledge and intense curiosity Multi-language fluency preferred (English, Malay)Physical RequirementsExperience with SOLIDWORKS or AutoCAD.Hands-on technical ability with assembly methodologies including locational methods, assemblysetup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc.Mechanical aptitude, technical ability, ability to read and understand technical drawings andundefinedTechnical knowledge of cam driven linkages, discrete component assembly, and automation Familiarity with machine user interfaces (HMIs / GUIs)Familiarity working within cGMP guidelines and ISO 13485/21FDA820 regulations.Experience working in a regulated industry, in particular consumable products.Have strong interpersonal and communication skills.Excellent attention to detail, organizational skills, and rigorous process disciplineThirst for knowledge and intense curiosityMulti-language fluency preferred (English, Malay)

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