NPI and Validation Engineer

Responsibilities

• Ensure the timely and effective launch of new products through early collaboration with systems and R&D teams
• Support Global Manufacturing Engineering in all equipment and process validation activities, including FAT, SAT, IQ, TMV, and PQ
• Assist in process improvements to support manufacturing objectives regarding quality, service, and cost
• Provide domestic support for international engineering teams and coordinate design transfer activities globally
• Autonomously interpret data to drive cost-saving projects and process development
• Maintain a cGMP compliant environment in accordance with FDA 21CFR820 and ISO 13485 standards

Requirements

• B.S. with 2+ years of relevant experience or a Master's degree with 1 year of experience
• Experience with medical device manufacturing process and equipment validation
• Proficiency with structured problem-solving tools such as DMAIC or Six Sigma
• Experience in data analysis using tools like Design of Experiments (DOE)
• Ability to work collaboratively within a Quality Management System (QMS)

Preferred Qualifications

• Hands-on technical ability with assembly methodologies, robotics, sensors, and pneumatic actuators
• Mechanical aptitude and the ability to read and understand technical drawings and manuals
• Technical knowledge of automation, discrete component assembly, and cam-driven linkages
• Familiarity with machine user interfaces (HMIs / GUIs)

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. Our flagship Omnipod 5 Automated Insulin Delivery System integrates with continuous glucose monitors to manage blood sugar with ease. We foster a culture of curiosity, innovation, and collaboration to improve health outcomes worldwide.