Job Summary

Position Overview:
The incumbent will be exposed to industrial development and medical device environment. He/she will provide support to area/field being assigned and completed tasks assigned by Engineers/Manager and within our cross division.

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:
• Ensure compliance with safety rules, HR policies, Quality policies, and employee guidelines.
• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485
• Support the NPI team in executing pFMEA remediation actions across manufacturing lines.
• Review and analyze process risks identified in pFMEA documents.
• Track remediation activities, action owners, and closure status using project trackers.
• Assist in collecting evidence and documentation to support risk mitigation implementation.
• Support cross-functional meetings involving Manufacturing, Quality, Operations, and Engineering teams.
• Help update process documentation, including work instructions, process flow diagrams, and control plans.
• Prepare project status reports and summarize key findings for management review.
• Participate in continuous improvement initiatives aimed at reducing process risks and improving product quality.
• Collaborate with Cross-Functional Teams: Work closely with design, development, testing, and production teams to gather requirements, provide updates, and ensure seamless integration of builds.
• Documentation and Record Keeping: Maintain comprehensive documentation (Protocol and Report) of build requests, processes, and outcomes. Ensure all records are up-to-date and easily accessible.
• Perform other duties as required




Education and Experience:
Minimum Requirements:
• Enrolled as BS or MS candidate in engineering course or at least final year in engineering course or similar field
MS Office (MS Word, Excel, Power Point, Outlook) and data analytics tools
• Only for Malaysian students

Preferred Skills and Competencies:
• Proficient in Microsoft Office
• 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
• Multi-language fluency preferred (English, Malay, Mandarin)

Position Overview:

The incumbent will be exposed to industrial development and medical device environment. He/she will provide support to area/field being assigned and completed tasks assigned by Engineers/Manager and within our cross division.

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:

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

• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485

• Support the NPI team in executing pFMEA remediation actions across manufacturing lines.

• Review and analyze process risks identified in pFMEA documents.

• Track remediation activities, action owners, and closure status using project trackers.

• Assist in collecting evidence and documentation to support risk mitigation implementation.

• Support cross-functional meetings involving Manufacturing, Quality, Operations, and Engineering teams.

• Help update process documentation, including work instructions, process flow diagrams, and control plans.

• Prepare project status reports and summarize key findings for management review.

• Participate in continuous improvement initiatives aimed at reducing process risks and improving product quality.

• Collaborate with Cross-Functional Teams: Work closely with design, development, testing, and production teams to gather requirements, provide updates, and ensure seamless integration of builds.

• Documentation and Record Keeping: Maintain comprehensive documentation (Protocol and Report) of build requests, processes, and outcomes. Ensure all records are up-to-date and easily accessible.

• Perform other duties as required

Minimum Requirements:

• Enrolled as BS or MS candidate in engineering course or at least final year in engineering course or similar field

• MS Office (MS Word, Excel, Power Point, Outlook) and data analytics tools

• Only for Malaysian students

Preferred Skills and Competencies:

• Proficient in Microsoft Office

• 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

• Multi-language fluency preferred (English, Malay, Mandarin)

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.