Senior Process Engineer: Lean Six Sigma for Biotech Manufacturing

Integra LifeSciences Corporation; Northern (KY); Hybrid; USD 51,000 - 71,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Sr. Process Engineer to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma tools. You will improve processing, layout, workflow, assets, assembly methods, and workforce usage to boost efficiency and lifecycle management.

Regulatory compliance with GMP, ISO 9001/13485, and global regulations is essential. You will lead cross-functional projects, validate processes, and drive improvements in

Qualifications

• Requires a bachelor’s degree in engineering or equivalent; 5+ years of experience; master’s degree with 3+ years preferred.
• Experience with statistical process control (SPC) tools; Lean Six Sigma required.
• Excellent organizational and English communication skills (oral & written).
• Sound interpersonal and employee development skills; PMP desired.
• Knowledge of ERP, MRP, and MS Office; cross-functional collaboration.
• Bilingual English/Spanish is a plus; strong written and verbal communication in both languages.

Responsibilities

• Develop cross-functional networks with EHS, product development, process technology, CoEs, facilities, quality, regulatory, planning, procurement.
• Lead value stream projects addressing quality, lifecycle management, and new product introductions.
• Initiate and execute engineering studies and validations (IQ/OQ/PQ/TMV); draft ECR/ECOs and drawings.
• Use SPC to analyze process data, improve yields, reduce scrap, and prevent defects.
• Conduct technical investigations, NC/CAPA, and CAPA investigations.
• Identify and justify projects for process, quality, reliability, and cost improvements using Lean Six Sigma tools.
• Ensure BOMs, routers, and work instructions reflect process changes and lifecycle.
• Complete process improvements to meet KPI targets; develop training programs.

Skills

SPC

Lean Six Sigma

Communication skills

PMP

ERP

MRP

MS Office

Bilingual Spanish/English

Project management

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

SAP

CRM platforms

MS Project

Jira

QMS platforms

Job description

Integra LifeSciences Corporation is seeking a Sr. Process Engineer to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma tools. You will improve processing, layout, workflow, assets, assembly methods, and workforce usage to boost efficiency and lifecycle management.

Regulatory compliance with GMP, ISO 9001/13485, and global regulations is essential. You will lead cross-functional projects, validate processes, and drive improvements in