Engineering Intern: Quality, Risk & NPI Support

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

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.