Senior Process Engineer I — Lean Six Sigma for Healthcare Impact

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

Job summary

Integra LifeSciences is seeking a Sr. Process Engineer to optimize and sustain manufacturing processes within a value stream, applying lean and six sigma methodologies to improve processing, layout, workflow, assets, and workforce efficiency.

You will lead cross-functional process and product teams, manage lifecycle sustaining changes, and ensure compliance with GMP, ISO 9001/13485, EU MDR, CMDR, and other regulatory requirements while driving process capability and cost improvements.

Qualifications

• Engineering degree with 5+ years of experience; master's with 3+ years acceptable.
• Experience with SPC tools and process improvement.
• Strong organizational and English communication skills.
• Knowledge in ERP, MRP, and MS Office.
• PMP is a plus.

Responsibilities

• Develop a cross-functional network to address process challenges, lifecycle and sustaining changes.
• Represent value stream teams in strategic site and enterprise projects.
• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, ECOs and engineering drawings.
• Leverage statistical process control to analyze and improve process parameters, yields and scrap.
• Perform investigations, non-conformance, FMEA and CAPA.
• Identify and lead projects to improve process, quality, reliability and cost using lean six-sigma tools.
• Ensure BOMS, routers, and work instructions align with lifecycle and cost accuracy.
• Develop hands-on training programs and lead cross-functional teams.
• Complete other job-related duties as assigned.

Skills

SPC / Minitab

Lean Six Sigma

English communication

Project management

ERP / MRP / MS Office

Education

Bachelor’s degree in engineering or equivalent

Master’s degree with 3+ years of experience

Tools

SAP

CRM platforms

MS Project

Jira

QMS platforms

Job description

Integra LifeSciences is seeking a Sr. Process Engineer to optimize and sustain manufacturing processes within a value stream, applying lean and six sigma methodologies to improve processing, layout, workflow, assets, and workforce efficiency.

You will lead cross-functional process and product teams, manage lifecycle sustaining changes, and ensure compliance with GMP, ISO 9001/13485, EU MDR, CMDR, and other regulatory requirements while driving process capability and cost improvements.