Senior Manufacturing Engineer
Core
Senior Manufacturing Engineer leading equipment implementation, validation, and roll-out to production lines for medical device solutions.
Role type
Senior Manufacturing Engineer (Validation & Equipment Implementation)
Builds
Medical device equipment and processes for global production lines
Domain
MedTech / Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP, GXP, CSV fundamentals, validation SME, change control, technical writing, URS/TM/FAT/IQ/OQ/PQ documentation, test plan design, global scaling of equipment
Preferred skills
metrology systems, vision systems, SCADA deployment, Lathing & Milling technologies
Technologies
SCADA, vision systems, metrology systems
Responsibilities
Lead validation activities from CR creation to closure, write validation protocols and reports, gather requirements and specifications for machines/equipment, support handover with documentation and training, communicate with R&D/QA/Operations/suppliers, implement equipment validation for global scaling, design and execute test plans
Seniority
Senior, hands-on IC