Associate Engineer, NPI & Validation Engineering

Associate Engineer, NPI & Validation Engineering

Insulet Corporation

Insulet started in 2000 with a mission to enable our customers to enjoy simplicity, freedom, and healthier lives through our Omnipod product platform. Over two decades, we have improved the lives of hundreds of thousands of patients with innovative, wearable, waterproof, and lifestyle‑accommodating technology.

We are seeking highly motivated, performance‑driven individuals to join our expanding team. Hiring is guided by shared values that exceed customer expectations.

Position Overview

NPI Associate Production Engineer is a critical member of the NPI Engineering team. This role is responsible for the development and execution of engineering verification projects, including Engineering Build, Verification Build, Characterization Build, and Design Verification Build. The primary responsibility is to manage and coordinate build requests, ensuring that technical specifications and requirements are met. The role requires close collaboration with cross‑functional teams—design, material supplier engineering, manufacturing engineering, and quality assurance—to streamline processes and optimize project timelines. Strong analytical skills, attention to detail, and clear communication of complex technical information are essential.

Responsibilities

• Work with Senior NPI Engineer to lead and support any New Product Introduction program at Insulet.
• Provide 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, ensuring changes do not affect product functionality, quality, or manufacturing process parameters.
• Collaborate with cross‑functional teams—design, development, testing, and production—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 (protocols and reports) of build requests, processes, and outcomes.
• Issue resolution : identify, troubleshoot, and resolve build‑related issues promptly to minimize downtime and meet project timelines.
• Quality assurance : implement and enforce quality control measures to ensure all builds meet 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 the plant engineering team as part of continuous improvement efforts.
• Ensure compliance with safety rules, quality policies, and employee guidelines.
• Maintain a cGMP‑compliant environment, operating within FDA 21CFR820 guidelines for manufacturing and ensuring compliance to ISO 13485.
• Perform other duties as required.

Preferred Skills And Competencies

Seniority level

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