Senior Engineer, Industrial Engineering

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 Engineer of Industrial Engineering will ensure that their daily activities support business objectives, comply with cGMP requirements, and ensure their performance/development is align with their manager. The Engineer of Industrial Engineering must put the safety of our people and patients first, be focused on quality, self-directed, a motivated team player, and a willing trainer—eager to gain and share new knowledge.  The normal schedule for this role is Monday through Friday but the plant is a 24/7 operation and will require flexibility to maintain standards across all shifts.

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:

• Use Lean principles and tools to drive a continuous improvement culture to improve safety, quality, efficiency, and cost.

• Ensure compliance with safety rules, quality policies, and employee guidelines.

• Build the capability of the Industrial Engineering department.

• Optimized production performance systems.

• Monthly review of direct labor headcount and capacity.

• Responsible for manufacturing supply control.

• Capacity analysis, review and build up.

• Lead and coordinate projects such as cost savings, efficiency, and material flow improvement.

• Work closely with the facilities engineering team for planning of equipment and facilities space in order to reduce the impact of major environmental factors and safety risk, master energy conservation and other environmental protection awareness.

• Responsible for reporting safety, quality, and regulatory compliance concerns to leadership.

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

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

• Author and implement engineering change orders (ECO) and process change orders within the MFG environment.

• Perform validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate execution of the

validation/qualification protocols and write validation/qualification reports.

• Possesses strong mechanical analysis skills.

• Perform other duties as required.

Education and Experience:

• Bachelor’s degree, or an equivalent combination of education and experience in industrial engineering or equivalent background.

• Minimum of 8 Years of experience within industrial engineering and lean environments

• 8 Years of experience in industrial engineering in a high-volume production environment.

• Process oriented and uses data to make decisions.

• Ability to fulfill job responsibilities in a fast-paced/high-volume production environment. 

• Demonstrated success using problem solving methodologies such as A3, PDCA, DMAIC, etc.

Preferred Skills and Competencies:

• Experience working in a regulated industry; Medical Devices or Pharma preferred.

• Certified Lean Six Sigma Black Belt or equivalent experience.

• Trainer for Lean Six Sigma.

• Familiar with SOLIDWORKS or AutoCAD.

• Familiar with ISO compliance such as ISO 9001, TS16949, ISO14001, OHSAS 18001.

• Familiar with data analysis tools such as Microsoft Power BI, TIBCO Spotfire, Tableau.

• Familiarity working within cGMP guidelines and ISO 13485/21FDA820 regulations.

• Proficient in Minitab.

• Proficient in computer skills, MS Word, Excel, Power Point, Outlook.

• Proficient in big data analysis computer skills, MS Word, Excel, Power Point, Outlook.

• Previous experience working in a clean room environment.

• Have strong interpersonal and communication skills.

• Excellent attention to detail, organizational skills, and rigorous process discipline.

• Ability to adapt quickly to changes in daily work plans and unplanned issues on equipment, maintaining a focus on productivity without compromising safety or quality.

• Thirst for knowledge and intense curiosity.

• Sound decision making using data.

• Multi-language fluency preferred (English, Malay)

Physical Requirements (if applicable):          

• Able to work all shifts and some weekends as required to support business objectives.

• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.