Process Engineer II — Lean Healthcare Manufacturing

Integra LifeSciences Corporation; Irvine (CA); On-site; USD 71,300 - 97,750; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Total Rewards program

Job summary

Integra LifeSciences Corporation seeks a Process Engineer in Irvine to understand, optimize, and sustain manufacturing processes within a lean framework. You will contribute to lifecycle management, sustain engineering changes, and drive process improvements compliant with GMP, ISO 9001/13485, and other regulatory standards.

You will collaborate with cross-functional teams to optimize process design, validation activities, and cost efficiency while maintaining quality and regulatory compliance

Qualifications

• Bachelor's degree in engineering or equivalent; 0–2 years experience.
• Statistical process control tools (SPC) knowledge.
• Lean Six Sigma experience.
• Strong English communication and teamwork skills.
• Proficient with MS Office.

Responsibilities

• Work cross-functionally 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.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, ECR/ECO, and Engineering Drawings for equipment and processes.
• Conduct statistical process control analysis and trend existing process parameters to improve yields and reduce scrap.
• Perform timely technical investigations, non-conformance, FMEA, and CAPA.
• Complete projects to drive process, quality, reliability and cost improvements leveraging lean six-sigma tools.
• Conduct time studies and align Bills of Materials and work instructions with process to ensure cost accuracy.
• Monitor performance metrics for value streams and develop improvement actions to meet KPIs.
• Develop hands-on training programs for product/process/equipment.

Skills

SPC

Lean Six Sigma

English communication

Project management

MS Office

Education

Bachelor's degree in engineering or equivalent

Tools

SAP ERP

MS Project

Jira

Job description

Integra LifeSciences Corporation seeks a Process Engineer in Irvine to understand, optimize, and sustain manufacturing processes within a lean framework. You will contribute to lifecycle management, sustain engineering changes, and drive process improvements compliant with GMP, ISO 9001/13485, and other regulatory standards.

You will collaborate with cross-functional teams to optimize process design, validation activities, and cost efficiency while maintaining quality and regulatory compliance