NPI Quality Engineer for Pilot & Clinical Builds

Insulet Corporation; Acton (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Insulet Corporation is seeking a Quality Engineer, NGP Programs to drive quality engineering across early-stage development and pilot manufacturing. You will ensure quality is embedded in prototype builds and enable successful design transfer to manufacturing, interfacing with R&D, Manufacturing Engineering, and Regulatory teams.

The role focuses on developing inspection strategies, risk management, and QMS alignment to FDA QSR, ISO 13485, and GMP standards, ensuring readiness for feasibility,

Qualifications

• Lead quality engineering activities for prototype, pilot, clinical, and development manufacturing builds.
• Establish inspection strategies and quality systems to enable scalable production.
• Support DFMEA, PFMEA, and risk management activities across development stages.

Responsibilities

• Lead quality engineering activities supporting prototype, pilot, clinical, and development manufacturing builds.
• Develop and maintain inspection plans, control plans, procedures, and quality standards for evolving products and processes.
• Define and implement inspection and test methodologies for development and pilot manufacturing.

Skills

Quality engineering

Root cause analysis

CAPA

Problem solving

Cross-functional collaboration

Job description

Insulet Corporation is seeking a Quality Engineer, NGP Programs to drive quality engineering across early-stage development and pilot manufacturing. You will ensure quality is embedded in prototype builds and enable successful design transfer to manufacturing, interfacing with R&D, Manufacturing Engineering, and Regulatory teams.

The role focuses on developing inspection strategies, risk management, and QMS alignment to FDA QSR, ISO 13485, and GMP standards, ensuring readiness for feasibility,