Process Engineer II: Lean Manufacturing & Process Optimization

Integra-Lifesciences; 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) savings plan

Job summary

Integra LifeSciences is seeking a Process Engineer to optimize and sustain manufacturing processes within a value stream using lean and six-sigma tools to improve efficiency and quality.

You will conduct validations (IQ/OQ/PQ/TMV), lead cross-functional teams, analyze SPC data, and drive cost, reliability, and process improvements across the product lifecycle in a GMP-regulated environment.

Qualifications

• Statistical process control tools desired (SPC, Minitab, other software).
• Lean Six Sigma experience desired.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Project management and process improvement experience desired.

Responsibilities

• Perform SPC analysis and trending of process parameters to improve yields and reduce scrap.
• Execute IQ/OQ/PQ/TMV validations and manage ECR/ECOs and equipment/process drawings.
• Lead cross-functional teams and participate in lifecycle management and sustaining engineering changes.
• Monitor KPIs and drive cost, quality, reliability improvements across value streams.
• Develop hands-on training programs for product/process changes.
• Conduct time studies and align BOMs/routers with process from transfer to lifecycle.

Skills

SPC

Lean Six Sigma

English communication

Project management

Process improvement

Education

Bachelor’s degree in engineering

Tools

SAP

CRM platforms

MS Project

Jira

QMS platforms

Job description

Integra LifeSciences is seeking a Process Engineer to optimize and sustain manufacturing processes within a value stream using lean and six-sigma tools to improve efficiency and quality.

You will conduct validations (IQ/OQ/PQ/TMV), lead cross-functional teams, analyze SPC data, and drive cost, reliability, and process improvements across the product lifecycle in a GMP-regulated environment.