Description

You own the engineering and technical leadership for complex, regulated software systems.

Responsibilities

• Drive best practices implementation for software systems development and product lifecycles across Digital Applications for connected Infusion Pump Platforms.
• Develop technical solutions for complex software system problems and deliver high-quality solutions on schedule.
• Lead cross-functional efforts to document user needs and translate them into system requirements.
• Lead risk analysis activities for Digital Applications software, from hazard capture through mitigation implementation.
• Participate in software design reviews and perform product backlog grooming as part of Agile execution.

Required Skills

• Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable systems.
• Experience with Digital Applications (SaMD, MDDS) connected to regulated electro-mechanical devices in a clinical environment.
• Experience developing in an Agile environment, including creating and maintaining product backlogs.
• Experience working within a regulated industry.
• Strong documentation and communication skills (oral and written).
• Experience with Infusion Pump Platforms.
• Familiarity with Commercial and Clinical stakeholder processes.

Key Skills

Education

Any Graduate