R&D Software Design Control Specialist - Medical Devices
Core
Ensure efficient and successful progress in new and sustain software projects for pathology staining instruments software for cancer diagnostics by executing software design control activities.
Role type
R&D Software Design Control Specialist (Medical Devices)
Builds
Pathology staining instruments software for cancer diagnostics
Domain
Medical Devices / Clinical Diagnostics / Software Lifecycle Engineering
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Design control, requirements engineering, design verification, change control, product risk management, defect management, documentation, regulatory compliance analysis, user needs analysis, cybersecurity risk assessment
Preferred skills
Knowledge of IEC 62304 and ISO 14971, Agile software development
Technologies
None explicitly stated
Responsibilities
Execute software design control activities adhering to Quality Management System, ensure regulatory compliance for pathology software products, contribute to product DDF (DHF) and documentation, analyze and convert user needs to product requirements and user stories, conduct software and cybersecurity risk assessments, collaborate with Test and Validation for design verification and validation execution
Seniority
Mid-level, hands-on IC
