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
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 the development of test methods, conduct validation studies including gage R&R, and support regulatory inspections and audits.
This position requires adherence to strict quality management systems, safety requirements, and FDA regulations while driving continuous improvement initiatives.
Matching Summary
Match Score: 75
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.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
5+ years of progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management standards
Experience with FDA regulations and QMS
Six Sigma Green Belt certification minimum
Nice-to-have
Six Sigma Black Belt certification preferred
Experience leading cross-functional project teams
Positive can-do attitude in high-energy environments
Knowledge of international regulatory standards
Ability to develop new test methods and tooling
Key Requirements
Bachelor's degree in engineering required
Minimum 5 years of relevant engineering experience