Device Development Assurance Scientist
Core
Lead and support Risk Management activities throughout the product development lifecycle for medical devices and combination products, ensuring compliance with international standards and regulatory requirements.
Role type
Device Development Assurance Scientist (Risk Management)
Builds
Medical devices and combination products
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management principles, Design Controls, Quality Management Systems (QMS), regulatory requirements knowledge, change control assessments, continuous improvement initiatives
Preferred skills
Regulatory submissions experience, combination product development, ISO 14971, IEC 62366, Lean, Six Sigma, Quality Engineering, Project Management
Technologies
ISO 14971, IEC 62366
Responsibilities
Lead and support Risk Management activities throughout the product development lifecycle; Develop and maintain Risk Management documentation in compliance with ISO 14971 and Design Control requirements; Partner with cross-functional teams to ensure products are safe, effective, and manufacturable; Act as the Risk Management Subject Matter Expert (SME); Identify, assess, mitigate, and communicate product risks; Monitor and evaluate risk-related data; Support change control assessments; Drive continuous improvement initiatives across Risk Management and Quality Management Systems.
Seniority
Mid-level, hands-on IC
