Design Assurance Engineer, Device Technical Operations ( 18 Months FTC )
Core
Provide Design Assurance oversight for the creation, maintenance, and transfer of technical documentation and manufacturing processes for medical devices and combination products.
Role type
Design Assurance Engineer (Medical Devices)
Builds
Technical documentation and manufacturing transfer processes for combination products and medical devices
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Assurance oversight, GMP manufacturing experience, technical report authoring, quality management, regulatory compliance knowledge
Preferred skills
Knowledge of MDR 2017/745, ISO 14971, ISO 13485, FDA 21 CFR Part 820
Technologies
ISO 13485, 21 CFR 820, MDR 2017/745, ISO 14971
Responsibilities
Provide Design Assurance oversight for the transfer of manufacturing of Devices and Combination Products from R&D to commercial manufacturing sites, Manage and approve change controls impacting device/combination products, Support device-related complaints and investigations to establish corrective actions
Seniority
Mid-level, hands-on IC
