Process Engineering Manager – Medical Device GMP Leader

Integra LifeSciences Corporation; Northern (KY); On-site; USD 73,000 - 102,000; Full time

Job summary

Integra LifeSciences Corporation seeks a Manager of Process Engineering for the Collagen/Lyo Value Stream. This role leads a team of engineers/technicians, ensuring safety, quality, and regulatory compliance while driving process improvements and successful transfers of new products.

The position emphasizes cross-functional collaboration, CAPA management, and project leadership to optimize yield, costs, and product integrity in a GMP environment.

Qualifications

• Engineering or technical degree required with leadership experience.
• Master's degree with 3+ years leading teams is a plus.
• Experience in regulated manufacturing environments (medical device/pharma) preferred.

Responsibilities

• Lead and develop a team of process engineers and technicians.
• Oversee safety and environmental program adherence across the site.
• Drive process improvements, yield optimization, and quality improvements.
• Manage CAPA, deviations, and validation activities (IQ/OQ/PQ).
• Coordinate cross-functional projects to ensure on-time delivery and cost targets.

Skills

Leadership

English communication

Financial acumen

MS Office & stats

Regulated environment

Six Sigma

Process improvement

Team management

Education

Engineering or Technical degree

Master's degree

Tools

SAP

MS Project

Jira

QMS platforms

Statistical analysis tools

Job description

Integra LifeSciences Corporation seeks a Manager of Process Engineering for the Collagen/Lyo Value Stream. This role leads a team of engineers/technicians, ensuring safety, quality, and regulatory compliance while driving process improvements and successful transfers of new products.

The position emphasizes cross-functional collaboration, CAPA management, and project leadership to optimize yield, costs, and product integrity in a GMP environment.