Primary Responsibilities
Lead application feature definition activities working cross-functionally with Software Development, Systems Engineering, Human Factors, Clinical Engineering, and other stakeholders.
Work in an Agile environment to define product vision and priorities in alignment with organizational strategy, customer needs, clinical workflows, and technical roadmaps.
Translate product roadmap features into well-defined product requirements including features, user stories, and acceptance test criteria.
Contribute to overall project success and define necessary activities to achieve desired business results.
Identify, quantify, communicate, and proactively manage technical and integration risks that may require cross-functional collaboration to resolve complex system interactions
Lead decomposition of system requirements and architecture into software requirements, interface definitions, technical implementation strategies, traceability, and verification approaches throughout the product lifecycle.
Play a key role in the software/hardware integration. Collaborate with Systems Verification, Pre-Clinical engineering, and other stakeholders to do root cause analysis and solution generation
Review software designs to ensure alignment with system intent, software requirements, interface definitions, cybersecurity requirements, and product quality objectives.
Drive technical decision-making through requirements analysis, architecture decomposition, risk assessment, stakeholder feedback, and data-driven evaluation of software design alternatives.
Ensure that all activities conform to Quality and compliance requirements
Provide technical leadership and mentorship across multiple engineering disciplines, influencing engineering practices, technical direction, and organizational capability development.
Required Qualifications
Bachelor’s degree in engineering (Computer, Electrical, Computer Systems, Systems, or Software), Computer Science, or related discipline
8+ years of software engineering design and development or systems engineering experience
Demonstrated expertise in C++ and object-oriented software development within complex systems.
Experience defining software-level architecture, managing technical tradeoffs, and translating system-level requirements and architecture into effective software requirements, interfaces, and software designs.
Experience serving as Product Owner or Product Manager within Agile development environments.
Experience with Agile frameworks including Scrum, SAFe, or related methodologies.
Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
Preferred Qualifications
Master’s degree in engineering (Computer, Electrical, Computer Systems, or Software), Computer Science, or related discipline
Demonstrated experience leading software development activities in compliance with IEC 62304, ISO 14971, FDA Quality System Regulations, and cybersecurity guidance for medical devices.
Medical device experience, specifically supporting cardiac mapping and/or ablation systems
Experience with medical imaging systems including echocardiography, CT, MRI, fluoroscopy, image processing, image-guided therapy, or image registration technologies.
Well versed in draft FDA Cybersecurity Guidance and GDPR
Demonstrated ability to provide technical leadership and mentorship
Experience with complex electromechanical systems including hardware, embedded firmware, disposables, and software
