Overview


This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables.


Responsibilities


+ Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, anduser stories.

+ Conduct risk management activities including risk analysis for system, software, and cybersecurity.

+ Lead systems integration efforts across various engineering disciplines.

+ Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971.

+ Ability to effectively work and communicate in technical cross-functional teams to develop new products.

+ Continuously improves process and work methodologies by interfacing with peers/cros...