Strong knowledge of statistics and minitab software
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs
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.
Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software like Minitab.
The role requires adherence to strict safety, environmental, and quality requirements, including FDA regulations and ISO standards, while supporting regulatory inspections.
Matching 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.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong knowledge of statistics and Minitab software
Experience with ISO14971 risk management
Knowledge of FDA regulations and QMS
Ability to lead cross-functional project teams
Expertise in CAPA and root cause analysis
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring junior engineers
Familiarity with international regulatory standards
Positive can-do attitude in high-energy environments
Experience with supplier quality management
Proficiency in continuous improvement methodologies
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
Ability to work independently and collaboratively
English communication competencies for non-US roles