Technologist, Transfer Projects
Core
Support the successful transfer of new medical device products into manufacturing by ensuring manufacturing readiness and contributing to commercial launches.
Role type
Senior IC manufacturing technologist (medical device transfer projects)
Builds
Production-ready manufacturing processes and equipment for cardiovascular medical devices
Domain
Medical device manufacturing / Supply chain operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing equipment validation and maintenance)
Required skills
Preventive maintenance of complex equipment, troubleshooting manufacturing equipment, root cause analysis, validation and qualification of equipment, writing impact assessment reports, executing feasibility studies and experiments, managing equipment non-conformance reports (ENCRs) and Out of Tolerance (OOTs), project management for new equipment validation, knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), CAD usage, manufacturing software proficiency (JDE, QMS, PLM, Maximo)
Preferred skills
Medical device industry experience, manufacturing operations experience, training lower-level employees, formulating work instructions
Technologies
JDE, QMS, PLM, Maximo, CAD
Responsibilities
Troubleshoot and recommend maintenance to limit downtime; Design, set-up and execute feasibility studies and tests for equipment validation; Perform scheduled and unscheduled preventive maintenance on complex equipment; Check for equipment failures and perform corrective actions; Collaborate with Quality on corrective actions and exception work orders; Review documentation to ensure proper cataloging and transfer for Engineering approval
Seniority
Senior, hands-on IC