The role requires adherence to Integer's core values including customer focus, innovation, and integrity while ensuring compliance with FDA and QMS requirements
Job Summary
The role requires adherence to Integer's core values including customer focus, innovation, and integrity while ensuring compliance with FDA and QMS requirements.
Key responsibilities include generating and executing validation protocols (IEQ, PQ, TMV, SWIQ) and supporting design verification testing alongside R&D teams.
The position offers a competitive salary range of $79,200-$116,160 along with immediate eligibility for comprehensive benefits including medical, dental, vision, and 401(k) matching.
Matching Summary
The role requires adherence to Integer's core values including customer focus, innovation, and integrity while ensuring compliance with FDA and QMS requirements.
Salary
Base: $79,200-$116,160; Bonus/Equity: Cash-based incentive program available; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match
Skills & Requirements
Must-have
Bachelor's degree in engineering
3+ years relevant experience
FDA regulations and ISO knowledge
Statistical software Minitab proficiency
Design verification and validation execution
Root cause analysis and CAPA support
Nice-to-have
SolidWorks mechanical design experience
Lean Six Sigma tools application
Strong technical writing skills
Collaborative cross-functional teamwork
Fixture design and test qualification
Key Requirements
Bachelor's degree in engineering or related field
Minimum three years of relevant experience
Knowledge of ISO and FDA quality systems
Experience with statistical methods like ANOVA and DOE