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Integer is seeking a Senior Engineer specializing in New Product Introduction (NPI) who will apply their extensive engineering knowledge to enhance product quality and innovation in the medical device sector. The ideal candidate will have significant experience in engineering roles, a strong technical foundation, and a commitment to collaboration and quality.
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Job Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs.
You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software like Minitab.
This position requires adherence to strict safety, environmental, security, and quality requirements including FDA regulations and ISO standards.
Matching Summary
Match Score: 75
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Integer is seeking a Senior Engineer specializing in New Product Introduction (NPI) who will apply their extensive engineering knowledge to enhance product quality and innovation in the medical device sector. The ideal candidate will have significant experience in engineering roles, a strong technical foundation, and a commitment to collaboration and quality.
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Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management
Experience with FDA regulations and QMS
Ability to lead cross-functional project teams
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Mentoring and coaching engineering staff
Experience with supplier quality management
Positive can-do attitude in high energy environment
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Knowledge of Domestic and International Regulations (ISO, QSR, UL)