Senior Process Engineer I: Lean Manufacturing for MedTech

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

Benefits offered by this job

401(k)

Benefits package

Job summary

Integra LifeSciences is seeking a Sr. Process Engineer to optimize and sustain manufacturing processes across value streams in a regulated environment.

The role emphasizes end-to-end process understanding, lifecycle management, and regulatory compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR, and related standards. The ideal candidate will drive process improvements using SPC/Lean Six Sigma, collaborate with EHS, quality, and product development, and lead multi-functional teams to achieve

Qualifications

• Bachelor’s degree in engineering or equivalent; 5+ years of experience.
• Lean Six Sigma experience required; SPC tools strongly preferred.
• Excellent organizational and English communication skills (oral & written).
• Experience working with cross-functional teams and driving process improvements.

Responsibilities

• Develop a cross-functional network 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, lifecycle management and NPI.
• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, specifications, ECR/ECO, and engineering drawings for equipment and processes.
• Leverage SPC to analyze and trend process parameters, improve yields, reduce scrap, and error-proof manufacturing processes.
• Perform timely technical investigations, non-conformance, FMEA, and CAPA.
• Identify, justify, and lead projects to drive process, quality, reliability and cost improvements using Lean Six Sigma.
• Ensure value stream BOMs, routers, and work instructions align with process and cost accuracy through lifecycle.
• Complete process improvements actions to meet KPI targets.
• Develop hands-on training programs for product/process/equipment.
• Lead cross-functional project teams across product development, QA, facilities, regulatory and manufacturing.
• Complete other job-related duties as assigned.

Skills

SPC

Lean Six Sigma

English comms

Project management

Cross-functional

Education

Bachelor’s degree in engineering

Master’s degree

Tools

SAP

MS Project

Jira

QMS platforms

CRM platforms

Job description

Integra LifeSciences is seeking a Sr. Process Engineer to optimize and sustain manufacturing processes across value streams in a regulated environment.

The role emphasizes end-to-end process understanding, lifecycle management, and regulatory compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR, and related standards. The ideal candidate will drive process improvements using SPC/Lean Six Sigma, collaborate with EHS, quality, and product development, and lead multi-functional teams to achieve