Quality Engineer - NPI Programs

Insulet Corporation•Acton, MA

About The Position

The Quality Engineer, NGP Programs is responsible for supporting quality engineering activities to facilitate early-stage product development and pilot manufacturing operations. This role operates at the intersection of Quality, R&D and Manufacturing, ensuring prototype and pilot builds are well-controlled and enable successful progression to clinical builds and eventual commercial scale. The individual will establish and execute quality strategies for pilot line operations, including inspection plans, risk management, and design transfer to manufacturing. Working closely with R&D, Manufacturing Engineering, and Clinical/Regulatory teams, this role ensures that builds are executed to internal processes and feasibility procedures and other GMP/ISO standards, as necessary then transitioning o Insulet’s Quality Management Systemwhile building the foundation for scalable, production-ready quality manufacturing processes. A critical responsibility is ensuring product quality readiness for internal feasibility, clinical and commercialization milestones—driving disciplined execution in pilot manufacturing while enabling an efficient, compliant design transfer to manufacturing. Position Overview The Quality Engineer, NPI Programs plays a critical role in supporting new product development and pilot manufacturing by ensuring quality is built into products and processes from the earliest stages of development through commercialization. Operating at the intersection of R&D, Manufacturing, and Quality , this individual will lead quality engineering activities for prototype, pilot, clinical, and pre-commercial manufacturing builds. The role is responsible for establishing and maintaining quality systems, inspection strategies, risk management processes, and design control compliance that enable efficient product development while creating a scalable foundation for commercial manufacturing. Working closely with cross-functional teams, including R&D, Manufacturing Engineering, Operations, Clinical, and Regulatory Affairs, the Quality Engineer ensures product and process readiness, regulatory compliance, and successful transfer from development into production.

Requirements

Bachelor's degree in engineering or a related technical discipline.
At least 3 years of Quality Engineering experience in a regulated industry.
Experience with inspection methods, metrology systems, test methods, and measurement system analysis.
Knowledge of FDA QSR (21 CFR 820) and ISO 13485 quality system requirements.
Understanding of design controls, risk management, and medical device quality systems.
Familiarity with Design History File (DHF) and Device History Record (DHR) requirements.
Experience supporting manufacturing operations, process development, pilot manufacturing, or New Product Introduction (NPI) programs.
Experience with equipment and process validation activities (IQ/OQ/PQ).
Knowledge of quality engineering tools, including root cause analysis, statistical analysis, and process capability studies.
Strong analytical, problem-solving, and cross-functional collaboration skills.

Nice To Haves

Medical device industry experience.
Experience supporting new product development (NPD) programs.
Experience with design controls, risk management, and manufacturing quality initiatives.
Demonstrated ability to drive quality improvements in a cross-functional environment.

Responsibilities

Lead quality engineering activities supporting prototype, pilot, clinical, and development manufacturing builds.
Develop and maintain inspection plans, control plans, procedures, work instructions, and quality standards for evolving products and manufacturing processes.
Define and implement inspection and test methodologies to support product development, pilot manufacturing, and release activities.
Ensure compliance with design controls, traceability requirements, quality systems, and product documentation throughout the development lifecycle.
Support Design History File (DHF) and Device History Record (DHR) compliance, lot release activities, and clinical build readiness.
Analyze quality and manufacturing data to identify trends, mitigate risks, and drive continuous improvement initiatives.
Lead investigations of nonconforming materials and products, conducting root cause analysis and implementing corrective and preventive actions (CAPA).
Facilitate risk management activities, including DFMEA, PFMEA, and development of process control strategies.
Support qualification and validation of manufacturing equipment, inspection systems, test methods, and production processes (IQ/OQ/PQ).
Partner with R&D and Manufacturing Engineering teams to improve product manufacturability, inspectability, reliability, and process capability.
Support manufacturing transfer and commercialization efforts through development of production quality controls and readiness assessments.
Ensure compliance with FDA Quality System Regulations, ISO 13485, GMP requirements, and applicable regulatory standards.