The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles to ensure the production of quality products for medical device OEMs
Job Summary
The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles to ensure the production of quality products for medical device OEMs.
Candidates will lead continuous improvement projects, manage complaint investigations, and support regulatory inspections while adhering to strict FDA regulations and ISO standards.
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 job is to apply intensive and diversified knowledge of engineering principles to ensure the production of quality products for medical device OEMs.
Salary
Base: $114,675 - $168,190; Bonus/Equity: Cash-based incentive program supporting pay-for-performance; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
6 Sigma Green Belt certification minimum
ISO QSR FDA regulatory knowledge
Statistical quality control Cpk DOE
Device History Records maintenance
Non-conforming material disposition
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt preferred
Mentoring and coaching engineers
5 Sigma journey participation
Cross-functional collaboration skills
Positive can-do attitude
Calm demeanor in high energy
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
6 Sigma Green Belt certification required
Knowledge of Domestic and International Regulations like ISO QSR UL MDD TGA