Senior Process Engineer - Lean Six Sigma for Med Devices

Integra LifeSciences Corporation; Montana; On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Dental insurance

Job summary

Integra LifeSciences is hiring a Sr. Process Engineer to optimize and sustain manufacturing processes, ensuring compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR and other regulatory standards.

The role emphasizes cross-functional collaboration, process validation, and lifecycle management across value streams. Requires a Bachelor’s in engineering and 5+ years of experience; Lean Six Sigma and SPC skills are essential.

Qualifications

• Bachelor’s degree in engineering or equivalent; 5+ years of experience; Master’s degree with 3+ years is a plus.
• Experience with SPC, Minitab or other stats software.
• Lean Six Sigma experience required; PMP desired.

Responsibilities

• Develop cross-functional network with EHS, product development, and facilities to address process challenges and lifecycle changes.
• Represent value stream teams in site and enterprise projects on cross-functional teams for quality improvements and lifecycle management.
• Initiate and execute IQ/OQ/PQ/TMV validations and Engineering Change Requests/Orders (ECR/ECO).
• Leverage SPC to analyze process parameters and improve yields while reducing scrap and errors.
• Lead CAPA investigations and drive cost, quality, and reliability improvements.

Skills

SPC experience

Lean Six Sigma

English communication

Project management

Regulatory awareness

Education

Bachelor’s degree in engineering or equivalent

Master’s degree (preferred)

Tools

SAP ERP

MS Project

Jira

Job description

Integra LifeSciences is hiring a Sr. Process Engineer to optimize and sustain manufacturing processes, ensuring compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR and other regulatory standards.

The role emphasizes cross-functional collaboration, process validation, and lifecycle management across value streams. Requires a Bachelor’s in engineering and 5+ years of experience; Lean Six Sigma and SPC skills are essential.