The role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device manufacturing sector
Job Summary
The role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device manufacturing sector.
Candidates will lead continuous improvement projects, manage complaint investigations, and support regulatory inspections while adhering to strict FDA and ISO standards.
The position offers a competitive salary range of $114,675 - $168,190 along with comprehensive benefits including immediate eligibility for medical, dental, vision, and 401(k) matching.
Matching Summary
The role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device manufacturing sector.
Salary
Base: $114,675 - $168,190; Bonus/Equity: Cash-based incentive program available; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company match
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
6-Sigma Green Belt certification minimum
ISO and QSR regulatory knowledge
FDA regulations compliance
Root cause analysis expertise
Statistical quality control methods
Nice-to-have
Master's degree preferred
Six Sigma Black Belt certification
Mentoring and coaching skills
5 Sigma journey participation
Cross-functional collaboration
Positive can-do attitude
Independent problem solving
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 (ISO, QSR, UL, MDD, TGA)