Senior Design Assurance Engineer CRM
Core
Support medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics division, focusing on quality-related activities for active implantable and accessory devices.
Role type
Senior Design Assurance Engineer
Builds
Active implantable and accessory devices, combination products with a drug component
Domain
Medical devices / Cardiac Rhythm Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design assurance, risk management, ISO 13485, ISO 14971, Quality System Regulations, design controls, verification, validation, usability testing, hazard analyses, FMEAs, Design History File maintenance
Preferred skills
Quality integration activities, Class III medical devices, Electrical Medical Equipment, Active Implantable Medical Devices, combination products with drug component, materials of animal origin
Technologies
ISO 13485, ISO 14971
Responsibilities
Apply systematic problem-solving methodologies to identify and resolve quality issues; Support Design Assurance acquisition integration activities related to risk management remediation; Support verification, validation and usability testing activities; Develop and maintain Design History File and Design Input/Output documentation; Generate and maintain product risk management tools including hazard analyses and FMEAs; Partner with R&D to determine and implement design controls based on risk management
Seniority
Senior, hands-on IC