What are the responsibilities and job description for the Senior Manufacturing Engineer position at United Pharma?
Senior Manufacturing Engineer Medical Device
Location: NC
Experience: 8 plus Years
About the Role:
We are seeking a Senior Manufacturing Engineer with strong experience in the medical device industry to support and improve manufacturing operations. This role focuses on process development, new product introduction, and ensuring compliance with regulatory and quality standards while driving efficiency and continuous improvement.
Key Responsibilities:
Develop, optimize, and maintain manufacturing processes for medical device production
Support new product introduction, process transfers, and scale up activities
Ensure compliance with FDA regulations, ISO 13485, and GMP requirements
Identify and resolve production issues using root cause analysis and corrective actions
Drive continuous improvement initiatives to enhance quality, yield, and efficiency
Collaborate with cross functional teams including Quality, R and D, and Operations
Support validation activities and documentation as required
Key Skills:
Medical Device Manufacturing
Process Development and Improvement
FDA, ISO 13485, and GMP Compliance
Root Cause Analysis and CAPA
Lean Manufacturing and Continuous Improvement
Required Qualifications:
Bachelor’s degree in Engineering or related field
8 plus years of experience in manufacturing engineering within medical devices
Strong understanding of regulatory requirements and production processes
Preferred:
Experience with process validation and NPI
Lean or Six Sigma certification