Intern, NPI &Test Engineering

Insulet Corporation; Gelang Patah; On-site; MYR 13,000 - 20,000; Full time

Job summary

Insulet Corporation is seeking an engineering-focused intern to support industrial development in a medical device environment, assisting engineers and managers across cross-divisional workstreams.

Role involves participating in risk analysis, documentation, and process improvement while maintaining compliance with cGMP, FDA 21 CFR 820, and ISO 13485 standards. Malaysian students only, engineering track, MS Office proficiency.

Qualifications

• Enrolled BS or MS candidate in engineering or final year in engineering or similar field.
• MS Office (Word, Excel, PowerPoint, Outlook) and data analytics tools.
• Malaysian students only.

Responsibilities

• Ensure compliance with safety rules, HR policies and quality policies.
• Maintain a cGMP/compliant environment and ISO 13485 adherence.
• Assist NPI team with pFMEA remediation across manufacturing lines.
• Review/process risks identified in pFMEA documents.
• Track remediation activities and closure status in project trackers.
• Support cross-functional meetings with Manufacturing, Quality, Operations and Engineering.
• Update process documentation including work instructions and control plans.
• Prepare project status reports and summarize findings for management.
• Collaborate with design, development, testing and production teams for builds integration.
• Maintain documentation (Protocol/Report) of build requests and outcomes.

Skills

Interpersonal skills

Multilingual (English, Malay, Mandarin

Education

Enrolled BS or MS in engineering

Final year in engineering or related field

Tools

MS Office

Data analytics tools

Job description

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.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!