ECI · 2 weeks ago
Senior Process Engineer - Technical Transfer - Medical Devices #0574 Charlotte, NC
Charlotte, NC
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expECI is a global leader in professional consulting services for the life sciences industry. The Senior Process Engineer will support cross-functional teams in transferring equipment used in the production of medical devices, ensuring compliance with regulatory requirements and quality standards while driving continuous improvement in manufacturing processes.
BiotechnologyConsultingLife ScienceProject Management
No H1B
Responsibilities
Development and Execution of Validation Protocols during tech transfer including: installation qualification, operational qualification, and performance qualification
Drive continuous improvement in transfer processes to ensure timely completion of deliverables and enhance operational efficiencies
Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards
Ensure products and processes meet specific standards
Provide Support for testing, analysis, and continuous improvement
Support updates to ECI’s client processes or other documentation as directed
Drive completion of Process Engineering activities within prescribed timeline
Manage injection modeling machines and molds (very large equipment)
Qualification
Required
Bachelor's degree in mechanical engineering, Life Sciences, or related field
8+ years of experience in medical device manufacturing, product development, or technology transfer
Proven track record supporting complex, multi-site projects in a regulated environment
Strong knowledge of design control, process validation, and manufacturing scale-up
Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution
Exceptional communication, collaboration and problem-solving skills
Experience with plastics processing, such as molding and/or extrusion a must
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase