Process Engineer II - Medical Manufacturing (Lean Six Sigma)

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)

Job summary

Integra LifeSciences in Irvine, CA is seeking a Process Engineer to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma tools. You will develop end-to-end process and product understanding, address lifecycle management, and drive sustaining engineering changes in compliance with GMP, ISO standards and regulatory requirements.

Key responsibilities include cross-functional collaboration across EHS, product development, and facilities, performing

Qualifications

• Bachelor's degree in engineering or equivalent
• Statistical process control tools desired (SPC, Minitab, other software)
• Lean Six Sigma experience desired
• Excellent organizational and English communication skills (oral & written)
• Project management and process improvement experience desired
• MS Office skills

Responsibilities

• Work cross-functionally with EHS, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to address process challenges, material changes, and lifecycle and sustaining changes.
• Represent value stream teams in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
• Conduct statistical process control analysis and trending of existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
• Perform timely technical investigations, non-conformance, FMEA, and CAPA.
• Complete projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
• Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with process to ensure cost accuracy from product transfer through product lifecycle.
• Monitor performance metrics for value stream(s) and develop improvement actions necessary to attain targeted performance KPI's.
• Develop hands-on product/process/equipment training programs.
• Participate in cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.

Skills

SPC (statistical process control)

Lean Six Sigma

MS Office

English communication

Project management

Education

Bachelor's degree in engineering

Tools

SAP

MS Project

Jira

Job description

Integra LifeSciences in Irvine, CA is seeking a Process Engineer to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma tools. You will develop end-to-end process and product understanding, address lifecycle management, and drive sustaining engineering changes in compliance with GMP, ISO standards and regulatory requirements.

Key responsibilities include cross-functional collaboration across EHS, product development, and facilities, performing