Senior Process Engineer: Lean Six Sigma & GMP Excellence

integralife; Añasco (PR); On-site; USD 51,000 - 71,000; Full time

Job summary

Integra LifeSciences is seeking a Sr. Process Engineer to understand, optimize, and sustain manufacturing processes across value streams, using lean and six sigma methodologies to improve efficiency.

You will ensure GMP, ISO 9001/13485, EU MDR, CMDR compliance and manage lifecycle changes from product transfer through lifecycle, leading cross-functional teams and driving improvements with strong project management skills.

Qualifications

• Bachelor's degree in engineering or equivalent; 5+ years of experience; master's with 3+ years is acceptable.
• Experience with SPC tools (Minitab or similar) required.
• Lean Six Sigma experience is required.
• Strong English communication skills, both written and verbal.
• PMP desired; project management experience preferred.
• Knowledge of ERP/MRP and MS Office.

Responsibilities

• Develop cross-functional networks with EHS, product development, process technology, CoE's, facilities, quality, regulatory, planning, procurement to address process challenges and lifecycle changes.
• Represent value stream teams in strategic site and enterprise projects on cross functional teams addressing quality improvements and lifecycle management.
• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specs, ECR/ECO, and engineering drawings for equipment and processes.
• Leverage statistical process control to analyze and trend process parameters, improve yields, reduce scrap, and error-proof manufacturing processes.
• Perform timely technical investigations, NC and CAPA.
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements using lean six-sigma tools.
• Ensure value stream BOMS, routers, and work instructions align with process and cost accuracy.
• Complete process improvements actions to attain KPI targets.
• Develop hands-on product/process/equipment training programs.
• Lead cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job-related duties as assigned.

Skills

SPC / Minitab / statistical tools

Lean Six Sigma

English communication

Project management

Engineering optimization

Education

Bachelor's degree in engineering or equivalent

Master's degree with 3+ years experience

Tools

SAP ERP

MS Project

Jira

CRM platforms

QMS software

Job description

Integra LifeSciences is seeking a Sr. Process Engineer to understand, optimize, and sustain manufacturing processes across value streams, using lean and six sigma methodologies to improve efficiency.

You will ensure GMP, ISO 9001/13485, EU MDR, CMDR compliance and manage lifecycle changes from product transfer through lifecycle, leading cross-functional teams and driving improvements with strong project management skills.