The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products that meet customer expectations
Job Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products that meet customer expectations.
You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages such as Minitab.
As a subject matter expert, you are expected to coach others, mentor engineers, and drive continuous improvement projects while adhering to strict FDA and ISO regulatory requirements.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products that meet customer expectations.
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
Positive can-do attitude under pressure
Key Requirements
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