Process Engineer II - Lean Med Device Manufacturing

Integra LifeSciences; Añasco (PR); On-site; USD 42,000 - 59,000; Full time

Job summary

Integra LifeSciences in Puerto Rico is seeking a Process Engineer to understand, optimize, and sustain manufacturing processes using lean and six sigma. You will develop end-to-end process understanding, drive capacity, layouts, and workflow improvements while ensuring compliance with GMP, ISO 9001/13485, EU MDR, and other regulations.

You will collaborate with EHS, product development, quality, and operations to execute validations, monitor KPI improvements, and lead cost and quality

Qualifications

• Bachelor’s degree in engineering or equivalent with 2-4 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)
• Positive, sound interpersonal, and employee development skills
• Project management and process improvement experience desired
• Knowledge in MS Office skills

Responsibilities

• Collaborate cross-functionally to address process challenges and changes.
• Represent value stream teams in site and enterprise projects.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing requirements and ECR/ECOs.
• Conduct SPC analysis to improve yields and reduce scrap.
• Perform technical investigations, NC and CAPA.
• Complete projects to drive process, quality, reliability and cost improvements using lean six-sigma tools.
• Conduct time studies and align Bills of Materials, work instructions, and routers.
• Monitor KPIs and develop improvement actions to meet targets.
• Develop hands-on training programs for product/process/equipment.
• Participate in cross-functional process and product project teams.
• Complete other job-related duties as assigned.

Skills

English communication

Organizational skills

Project management

Interpersonal skills

Spanish language

Education

Bachelor’s degree in engineering or equivalent

Tools

MS Office

SPC / Minitab

Lean Six Sigma

Job description

Integra LifeSciences in Puerto Rico is seeking a Process Engineer to understand, optimize, and sustain manufacturing processes using lean and six sigma. You will develop end-to-end process understanding, drive capacity, layouts, and workflow improvements while ensuring compliance with GMP, ISO 9001/13485, EU MDR, and other regulations.

You will collaborate with EHS, product development, quality, and operations to execute validations, monitor KPI improvements, and lead cost and quality