Scientist/Engineer, Device Technical Operations (Analytical) (18 Month Fixed Term Contract)
Core
Provide technical support for transferring medical device and combination product manufacturing from R&D to commercial sites, acting as an interface between development and production teams.
Role type
Scientist/Engineer, Device Technical Operations (Analytical)
Builds
Medical devices and combination products for commercial manufacturing
Domain
Medical Devices / Regulatory Compliance (GMP, ISO 13485, FDA 21 CFR)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical transfer, GMP manufacturing environment experience, authoring technical reports, regulatory documentation, problem solving, time management
Preferred skills
Knowledge of MDR 2017/745, ISO 13485, FDA 21 CFR Part 820 Design Control
Technologies
None stated
Responsibilities
Provide technical support for manufacturing transfer, act as interface between R&D and commercial sites, manage and approve change controls, develop manufacturing process understanding, support device-related investigations and root cause analysis, generate technical documentation (requirements, test methods, specifications, verification protocols)
Seniority
Mid-level, hands-on IC
