Engineering Consultant I/II - R&D - Medical Device #0359

Sobre esta oportunidad

About the role This role primarily supports design development activities from a documentation perspective, ensuring accurate and timely updates to the Design History File, including Design Inputs/Outputs, Verification and Validation, Risk Management, and CAPA/NC. It involves working closely with cross-functional teams to gather, organize, and maintain technical documentation, while providing clear communication to stakeholders and supporting overall project compliance and traceability. What you'll doReview the following documentation and perform a gap analysis:Bill of Materials (BOMs) Complaints Design Matrix Design Validation protocols and reports Design Verification protocols and reports Incoming Inspections Lists of Applicable Standards Manufacturing Tools Preventive Maintenance Process Validation protocols and reports Product Drawings Production Methods Risk Management documents Test Methods and Test Method Validations Tolerance Analysis Usability documents User Needs and Design Requirements documents Prepare and maintain a Project Tracker with weekly updates for Management Review.

Knowledge transfer to client during and at completion of the project. Other tasks as agreed upon between the Liaisons listed in this Statement of Work. English-B2+