Lean Six Sigma Process Engineer (Medical Devices)

Integra LifeSciences Corporation; United States; On-site; USD 42,000 - 59,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Manufacturing Process Engineer in the US‑PR Anasco facility. You will understand, optimize, and sustain manufacturing processes using lean and six‑sigma tools to improve efficiency, layout, and workflow across value streams.

You will develop end‑to‑end process understanding, manage lifecycle and sustaining changes, and ensure compliance with GMP, ISO 9001/13485 and related regulations while collaborating with EHS, product development, and quality

Qualifications

• Bachelor’s degree in engineering or equivalent with 0-2 years of experience.
• Statistical process control tools desired (SPC, Minitab, other software).
• Lean Six Sigma Experience Desired.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Project management and process improvement experience desired.
• Knowledge in 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, 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 scrap, and error proof processes.
• Perform timely technical investigations, non-conformance, FMEA, and CAPA.
• Complete projects to drive process, quality, reliability and cost improvements leveraging lean six-sigma tools.
• Conduct time studies, process evaluations, and technical evaluations to align BOMs, work instructions, and routers with processes for cost accuracy from transfer to lifecycle.
• Monitor performance metrics for value streams and develop improvement actions to achieve KPI targets.
• 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.
• Complete other job-related duties as assigned.

Skills

SPC tools

Lean Six Sigma

English communication

Project management

MS Office

Education

Bachelor’s degree in engineering or equivalent

Job description

Integra LifeSciences Corporation is seeking a Manufacturing Process Engineer in the US‑PR Anasco facility. You will understand, optimize, and sustain manufacturing processes using lean and six‑sigma tools to improve efficiency, layout, and workflow across value streams.

You will develop end‑to‑end process understanding, manage lifecycle and sustaining changes, and ensure compliance with GMP, ISO 9001/13485 and related regulations while collaborating with EHS, product development, and quality