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Senior Process Engineer I at Integra LifeSciences - ApplyBlast

Senior Process Engineer I

Integra LifeSciences

4 months ago

3.1 on Glassdoor

Utah, United States

Hybrid

Full Time

Senior

0 applicants

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About this role

A Sr. Process Engineer at Integra LifeSciences optimize manufacturing processes using Lean Six Sigma methodologies to improve efficiency, quality, and cost-effectiveness within regulatory-compliant environments. The role involves leading cross-functional projects, managing lifecycle sustaining engineering changes, and implementing data-driven process improvements to advance patient outcomes. Collaboration with departments such as quality, regulatory, and facilities is essential to drive continuous improvement in healthcare device production.

Responsibilities

Optimize manufacturing processes using Lean Six Sigma tools to improve efficiency
Lead cross-functional projects for lifecycle sustaining engineering changes
Develop and implement IQ/OQ/PQ/TMV validations and engineering change requests
Analyze process data to reduce scrap rates and improve manufacturing yields
Ensure compliance with FDA, GMP, and ISO regulatory standards in production

Skills

Qualifications

Bachelor's degree in EngineeringMaster's degree preferred5+ years of engineering experiencePMP certification desiredExperience with ISO 13485 and FDA regulations