The primary purpose of this role is to apply intensive knowledge of engineering principles to ensure customer expectations are met or exceeded while developing unique approaches to complex problems
Job Summary
The primary purpose of this role is to apply intensive knowledge of engineering principles to ensure customer expectations are met or exceeded while developing unique approaches to complex problems.
Candidates will lead continuous improvement projects, manage complaint investigations, and support regulatory inspections while adhering to strict FDA and QMS requirements.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching.
Matching Summary
The primary purpose of this role is to apply intensive knowledge of engineering principles to ensure customer expectations are met or exceeded while developing unique approaches to complex problems.
Salary
Base: $114,675 - $168,190; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
6-Sigma Green Belt certification minimum
Knowledge of FDA regulations and ISO standards
Experience with QMS and Device History Records
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification preferred
Strong written and oral communication skills
Ability to mentor and coach engineers
Positive can-do attitude in high-energy environment
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
6-Sigma Green Belt certification required
Knowledge of Domestic and International Regulations