Process Engineer II: Lean Six Sigma for Medical Devices

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

Job summary

Integra LifeSciences is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma methods. You will develop end-to-end process knowledge, support lifecycle management, and ensure compliance with GMP, ISO 9001, ISO 13485, EU MDR and CMDR regulations.

The role requires collaboration across EHS, product development, process technology, facilities, quality, regulatory, planning, and procurement to address process

Qualifications

• Bachelor's degree in Chemical/Mechanical Engineering or related field.
• Minimum of 3 years in engineering; medical device industry experience is a plus.
• Lean Six Sigma experience is a plus.
• Cleanroom manufacturing experience is a plus.
• Computer proficiency.

Responsibilities

• Work cross-functionally with EHS, product development, process technology, facilities, quality, regulatory, planning, and 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 SPC analysis and trending to improve yields, reduce scrap, and error-proof manufacturing processes.
• Perform timely technical investigations, CAPA, and FMEA, and drive cost improvements via lean six-sigma tools.

Skills

Lean Six Sigma

Computer proficiency

Education

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline

Job description

Integra LifeSciences is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma methods. You will develop end-to-end process knowledge, support lifecycle management, and ensure compliance with GMP, ISO 9001, ISO 13485, EU MDR and CMDR regulations.

The role requires collaboration across EHS, product development, process technology, facilities, quality, regulatory, planning, and procurement to address process