Senior 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.

Job Title: Senior Manufacturing Engineer - Malaysia

Department: Engineering

Position Overview:

The Plant Manufacturing Engineer is a critical member of the plant engineering and operations

teams. This role is responsible for reliability engineering, monitoring, and standardizing the

manufacturing process, anticipating, and resolving bottlenecks to capacity, driving uniformity of

maintenance and operations principles, identifying, and implementing cost and waste reductions, and

general continuous improvement of the site. The successful candidate will have strong structured

problem-solving skills of complex component and machine interactions and be comfortable working

hands-on with automation 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 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:

Bachelor’s degree in an engineering discipline Minimum 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

tools

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) 

Physical Requirements:       

Able to work all shifts and some weekends as required to support business objectives. Possess the ability to stand and move for long hours per shift. Required to reach above shoulder frequently and below waist occasionally. Required to push and pull. Ability to lift 9 kg occasionally, 2-9 kg frequently.