A demonstrated technical leader with proven systems and software engineering experience in the context of the medical device industry.
Valuable experience in all aspects of medical device development, from research through regulatory approval and commercialization.
Experience includes:
* Employing principles of Human-Centered Design to gather voice of customer, business, regulatory, and other stakeholders in order to derive meaningful requirements
* Shepherding a cross-functional technical team in the allocation of system requirements and architecture to product and functional specifications
* Coordinating the derivation of meaningful designs from standards and regulations (ISO 62304, EN 60601-1, MDD, etc)
* Mentoring others in the development of sufficient test designs to characterize and iterate designs early and ensure successful verification and validation of the system and components
* Developing and executing a strategy for manufacture and distribution of production units
* Initiating activities to develop and improve processes and procedures to facilitate efficient system development and ensure development activities are compliant to regulatory requirements and expectations
Possesses a depth of knowledge in the management of software development for both embedded implantable and therapy programming platforms, having managed projects under ISO-62304 as a lead technical contributor. He has driven functional initiatives to improve adherence of current software development processes to these and other guidelines.
Brandon seeks further opportunities to leverage his passion and breadth of knowledge to drive the commercialization of innovative new technologies that will revolutionize outcomes for patients with chronic disease.