Associate Process 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.

Position Overview:

The Associate Process Engineer is responsible for developing, implementing, and optimizing manufacturing processes to improve yield, efficiency, quality, and cost. The role supports daily production by troubleshooting process issues, minimizing downtime, and ensuring stable operations through effective process control, SPC, and KPI monitoring.

The engineer leads continuous improvement initiatives such as cycle time reduction, yield improvement, scrap reduction, and cost optimization, while maintaining robust process documentation including SOPs, WIs, Control Plans, and PFMEAs. Responsibilities also include process capability analysis, root cause investigations, and implementation of corrective and preventive actions following structured problem‑solving methodologies.

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

• Develop, implement, and optimize manufacturing processes to improve yield, efficiency, quality, and cost
• Support production lines by troubleshooting process issues and reducing downtime
• Lead process improvement projects (Cycle Time reduction, Yield improvement, Scrap reduction)
• Establish and maintain process documentation (SOPs, WI, Control Plans, PFMEA)
• Perform process capability studies (Cp, Cpk) and data analysis
  • Monitor and control Critical Process Parameters (CPP)
  • Use SPC tools to maintain process stability
  • Define and track process KPIs (Yield, Scrap, OEE)
  • Support failure analysis and corrective/preventive actions
  • Ensure process changes follow ECN / PCN procedures
• Introduce and validate new equipment, materials, or processes
• Support New Product Introduction (NPI) and process qualification
• Conduct root cause analysis and corrective actions (8D, Fishbone, 5‑Why)
• Lead or participate in Lean, Six Sigma, Kaizen activities
• Prepare technical reports and presentations
• Maintain engineering records and change documentation
• Present process performance to management and customers
• Responsible for Non‑Conformance Material Reports (NCMR), Corrective and Preventive Actions (CAPA), and customer complaints management.
• Drive cost reduction and productivity improvement initiatives
• Support automation, AI and Industry 4.0 initiatives where applicable
• Work closely with Production, Quality, Maintenance, and Supply Chain teams
• Support customer audits, internal audits, and regulatory requirements
• Ensure compliance with ISO13845.

Education and Experience:

Minimum Requirements:

• Hands-on experience in setup and operation of automated production equipment is preferred
• Advanced proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analytics
• 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:

• Data analysis (Excel, Minitab)
• SPC & Statistical analysis
• Problem‑solving tools (DMAIC)
• Strong analytical and problem‑solving skills
• Hands‑on and shop‑floor oriented
• Ability to work cross‑functionally
• Good documentation and presentation skills
• Able to work under pressure and tight deadlines
• 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)