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The Integer Group is seeking a Senior Engineer for New Product Introduction (NPI) to apply advanced engineering principles in developing innovative solutions for medical devices and specialized batteries. The ideal candidate will possess extensive engineering experience, strong problem-solving skills, and a commitment to quality and continuous improvement, while embracing the company's core values of customer success, innovation, collaboration, inclusion, candor, and integrity.
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Job Summary
This role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
The engineer will lead test method development, statistical analysis using Minitab, and root cause analysis while supporting regulatory inspections.
Candidates must adhere to strict safety, environmental, and FDA regulations while driving continuous improvement and quality KPI attainment.
Matching Summary
Match Score: 75
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The Integer Group is seeking a Senior Engineer for New Product Introduction (NPI) to apply advanced engineering principles in developing innovative solutions for medical devices and specialized batteries. The ideal candidate will possess extensive engineering experience, strong problem-solving skills, and a commitment to quality and continuous improvement, while embracing the company's core values of customer success, innovation, collaboration, inclusion, candor, and integrity.
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Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis using Minitab
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
Six Sigma Black Belt certification
Mentoring and coaching engineers
Cross-functional team leadership
Continuous improvement mindset
Strong written and oral communication
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Knowledge of ISO, QSR, UL, MDD, TGA standards
Strong working knowledge of Statistics and Minitab