Supplier Engineer - Validation

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 Supplier Engineer – Validations plays a key role in Insulet’s Global Procurement and Supplier Development organization, supporting the validation and integration of precision components into our automated assembly lines in Malaysia. This position is ideal for early-career engineers with 1 to 5 years of experience who are passionate about driving quality and process excellence in a dynamic, cross-functional environment.

This role involves managing Component Validation Plans (CVPs), coordinating validation activities with suppliers, and ensuring successful implementation through Insulet’s manufacturing processes. The engineer will work closely with Quality, Automation, Sourcing, and other internal teams to ensure alignment and compliance with regulatory and internal standards.

Key Responsibilities

• Manage validation timelines and ensure on-time delivery (OTD) of all validation milestones.

• Manage and execute component validation activities from suppliers through Insulet Malaysia’s automation lines.

• Develop and implement Component Validation Plans (CVPs), including protocol creation, testing coordination, and report documentation.

• Collaborate with cross-functional teams to ensure validation activities are aligned with project timelines and quality requirements.

• Support root cause investigations and corrective actions related to component performance and integration issues.

• Communicate effectively with suppliers to understand manufacturing processes and drive improvements.

• Ensure validation documentation meets internal and regulatory compliance standards.

• Participate in continuous improvement initiatives to enhance component quality and manufacturability.

• Provide regular updates to stakeholders on validation progress, risks, and mitigation plans.

Minimum Requirements:

• Bachelor’s degree in Mechanical, Industrial, Manufacturing, Plastics, or Biomedical Engineering.

• 2 to 4 years of relevant engineering experience, preferably in a manufacturing, validation, or supplier-facing role.

Preferred Skills and Competencies

• Familiarity with component validation and qualification processes.

• Exposure to injection molding, tooling, or automation systems is a plus.

• Strong communication and collaboration skills across technical and non-technical teams.

• Detail-oriented with strong documentation and organizational abilities.

• Experience with statistical tools (e.g., Minitab, JMP) is an advantage.

• Proficient in Microsoft Office; experience with project tracking tools is a plus.

• Self-driven, adaptable, and capable of managing multiple priorities in a fast-paced environment.

• Perform other duties as assigned.

• Power BI Experience.

Physical Requirements (if applicable):        

• Ability to travel domestically and internationally – 10% typical