Senior Value Stream Leader, Medical Device Manufacturing

Integra LifeSciences; Añasco (PR); On-site; USD 87,000 - 122,000; Full time

Job summary

Integra LifeSciences in United States is seeking a Senior Manager, Value Stream Leader to oversee the end-to-end Tissue Technology production value stream, including design transfers, lifecycle management, and final device shipment.

You will lead safety, quality, regulatory, engineering, and operations, drive Lean/Six Sigma improvements, manage budgets, and ensure on-time delivery while maintaining compliance with FDA QSR, ISO 13485, and other standards.

Qualifications

• Engineering or technical degree with 8+ years leading a team.
• Master’s degree with 5+ years of leadership.
• Strong English communication skills.
• Experience in regulated medical device environments.
• Proficiency with ERP, QA systems, and data analysis tools.

Responsibilities

• Oversee end-to-end Tissue Technology value stream, ensuring safety, quality, and productivity.
• Lead staffing, training, and daily operations across shifts.
• Partner with Quality and Regulatory to ensure FDA/ISO compliance.
• Drive Lean/Six Sigma initiatives and cost control.
• Develop and manage budgets and COGS in the value stream.
• Collaborate with cross-functional teams to meet customer needs.

Skills

English communication

Leadership

Regulatory awareness

MS Office

Statistical analysis

Education

Engineering or Technical degree

Master’s degree

Tools

Oracle

Jira

MS Project

QMS platforms

ERP systems

Job description

Integra LifeSciences in United States is seeking a Senior Manager, Value Stream Leader to oversee the end-to-end Tissue Technology production value stream, including design transfers, lifecycle management, and final device shipment.

You will lead safety, quality, regulatory, engineering, and operations, drive Lean/Six Sigma improvements, manage budgets, and ensure on-time delivery while maintaining compliance with FDA QSR, ISO 13485, and other standards.