Maintenance 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.

Responsibilities:

• Accountable to driving maintenance process improvements in support of Insulet’s primary

manufacturing objectives: Best Quality, Best Service, Best Cost.

• Autonomously interprets data to drive plant decision making and prioritization of reliability

efforts.

• 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 operations

teams as part of continuous improvement efforts.

• Independently maintains and publishes operating scorecard to track and trend

projects/improvements.

• Create and modify preventive maintenance tasks and work plans to move unplanned emergency

events to planned maintenance events.

• Responsible to assign/manage the technical resources and be accountable to verify the

PM is effective

• Maintain direct hands-on interaction with the manufacturing equipment including station set-up

and 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 required

Education and Experience:

Minimum Requirements:

• More than 5 years of experience working directly on automated manufacturing equipment

• Hands-on experience in setup and operation of automated production equipment

• Advanced proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analytics

• undefined

• Process 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, assembly

setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc.

• Mechanical aptitude, technical ability, ability to read and understand technical drawings and

manuals.

• 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)