Associate Engineer, NPI & Validation Engineering

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!

Position Overview

NPI Associate Production Engineer is a critical member of the NPI Engineering team. This role is responsible in the development and execution of engineering verification projects, inclusive but not limited to Engineering Build, Verification Build, Characterization Build, and Design Verification Build . The primary responsibility will be to manage and coordinate build requests, ensuring that all technical specifications and requirements are met. This role requires working closely with cross-functional teams, including design team, Material Supplier Engineering, manufacturing Engineering, and quality assurance, to streamline processes and optimize project timelines. This role is expertise in engineering principles and project management will be crucial in identifying potential issues and implementing effective solutions. This role demands strong analytical skills, attention to detail, and the ability to communicate complex technical information clearly. By driving efficiency and innovation, you will contribute significantly to the successful delivery of high-quality engineering projects.

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

• Work with Senior NPI Engineer to Lead and support any New Product Introduction program that will be taken by Insulet.
• Weekly Beat the Plan progress reports on project deliverables and timelines.
• Manage Engineering Build Requests : Oversee the entire lifecycle of engineering build requests, from initial submission to final delivery, ensuring all requirements are met.
• Conduct all verification builds to validate changes in materials, suppliers, processes, or test methods against current mass production standards. Ensure that changes do not affect product functionality, quality, or manufacturing process parameters.
• 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.
• Build Process Optimization : Continuously evaluate and improve build processes to enhance efficiency, reduce errors, and streamline workflows.
• 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.
• Issue Resolution : Identify, troubleshoot, and resolve build‑related issues promptly to minimize downtime and ensure project timelines are met.
• Quality Assurance : Implement and enforce quality control measures to ensure all builds meet the required standards and specifications.
• Reporting and Communication : Provide regular updates and detailed reports on build status, progress, and any issues to stakeholders and management.
• Develop and deliver training to build the capability of plant engineering team as part of continuous improvement efforts
• Ensure compliance with safety rules, quality policies, and employee guidelines
• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485
• Perform other duties as required

Preferred Skills and Competencies

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