Specialist Design Transfer Operations (m/w/d), befristet auf 2 Jahre
Core
Support technical leadership in design transfer by independently handling operational work packages, creating and maintaining required documentation, and executing defined production preparation activities within a regulated IVD environment.
Role type
Specialist Design Transfer Operations
Builds
Automated blood analysis systems for allergy and autoimmune diseases
Domain
In-Vitro Diagnostics (IVD), Life Sciences, Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical or natural science education, experience in regulated environments (medical devices, IVD, pharma, life sciences), technical documentation management, document management systems, MS Office
Preferred skills
IVDR or ISO 13485 knowledge, SAP experience, master data processes, design transfer or production preparation experience
Responsibilities
Create and maintain design transfer documents, prepare production preparation plans, compile documentation packages for reviews, update project records in document management systems, track status lists and action items, prepare release documents, execute operational tasks in the production preparation process, document review results, support Device Master Record creation, manage product plant data and material master data, create presentations and status overviews
Seniority
Specialist, hands-on IC
