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ECI · 2 weeks ago

Senior Process Engineer - Technical Transfer - Medical Devices #0573 Taunton, MA

Taunton, MA

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

ECI 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.

BiotechnologyConsultingLife ScienceProject Management

Growth Opportunities

No H1B

U.S. Citizen Only

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

Process validationMedical device manufacturingRegulatory complianceDesign controlPlastics processingCommunication skillsCollaboration skillsProblem-solving skills