Not specified (assumed on-site based on industry standards).
Bachelor's degree in engineering
5+ years progressive engineering experience
Strong statistical analysis skills with minitab
Integer is seeking a skilled NPI Quality Engineer III to ensure high-quality product standards within New Product Introduction projects. The ideal candidate will possess extensive engineering experience and a strong foundation in problem-solving methodologies, particularly in a regulated environment
Job Summary
The primary purpose of this role is to apply intensive knowledge of engineering principles to New Product Introduction projects while ensuring customer expectations are met.
Candidates will lead cross-functional teams to support regulatory inspections, audits, and the development of new test methods including gage R&R studies.
The successful engineer will drive continuous improvement initiatives and ensure compliance with ISO14971 risk management and FDA regulations throughout the product development process.
Matching Summary
Match Score: 85
Integer is seeking a skilled NPI Quality Engineer III to ensure high-quality product standards within New Product Introduction projects. The ideal candidate will possess extensive engineering experience and a strong foundation in problem-solving methodologies, particularly in a regulated environment.
Skills & Requirements
Must-have
Bachelor's degree in engineering
5+ years progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management
Experience with FDA regulations and QMS
Six Sigma Green Belt certification minimum
Nice-to-have
Black Belt Six Sigma certification preferred
Cross-functional team leadership experience
Positive can-do attitude in high energy environment
Experience with continuous improvement methodologies
Ability to develop new test methods and tooling
Key Requirements
Bachelor's degree in engineering or related field
Minimum 5 years of progressive engineering experience
Six Sigma Green Belt certification required
Six Sigma Black Belt certification preferred
Strong working knowledge of statistics and Minitab