This role involves leading the development of new test methods, fixtures, and templates while ensuring NPI projects meet strict quality standards for medical devices
Job Summary
This role involves leading the development of new test methods, fixtures, and templates while ensuring NPI projects meet strict quality standards for medical devices.
The successful candidate will coach cross-functional teams, manage regulatory inspections, and drive continuous improvement initiatives aligned with ISO and FDA requirements.
Integer fosters a culture of innovation and collaboration where employees are expected to uphold core values like candor, integrity, and customer focus while pursuing excellence.
Matching Summary
This role involves leading the development of new test methods, fixtures, and templates while ensuring NPI projects meet strict quality standards for medical devices.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Minitab statistical analysis expertise
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
Process validation and capability studies
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Experience mentoring junior engineers
Strong written and oral communication skills
Positive can-do attitude in high energy environment
Key Requirements
Minimum Bachelor's degree in Engineering
7+ years of relevant engineering experience
Six Sigma Green Belt (Black Belt preferred)
Knowledge of ISO, QSR, UL, MDD, TGA standards
Strong working knowledge of Statistics and Minitab