Head of Engineering and Operations

Position Description
We are seeking a talented and inspired senior engineering and operations leader with a strong background in
both software and hardware to join our team in a full-time role. The successful candidate will lead our engineering
team through the development and enhancement of our ultrasound imaging platform and software that utilizes AI
(deep learning) to enable healthcare personnel without ultrasound training to take quantitative measurements of
blood flow and vessel morphology. This individual will be responsible for management of the engineering team
and projects including the support of software and hardware currently being used in clinical studies as well as
multiple NIH grant backed pipeline projects.

Technical and Personnel Leadership
• Lead software and hardware projects focused on the development of new products and
improvements to existing products through an understanding of the underlying science and
technology, which includes ultrasound imaging, module-based multi-threaded software, and AI (deep
• Create product development goals which are linked with business priorities and traced to individual
engineering responsibilities. Provide day-to-day management, oversight, and technical mentorship to
engineering team members.
• Support technical development of projects and people through requirement identification and
definition, product design, and testing plan. Lead brainstorming and problem-solving efforts. Drive and
lead innovative problem resolution at an accelerated pace.
• Lead team through interpretation of clinical and user feedback into actionable user needs, through
early prototyping, workflow conceptualization and finalization of features.

Program & Project Management
• Coordinate the efforts of multidisciplinary teams of internal resources and external
partners/subcontractors to successfully execute product development activities under QMS
compliance with FDA regulations.
• Create and maintain product and project management resources such as project plans, roadmap,
milestones, and timelines (Gantt charts). Identify critical path and adjust development accordingly.
• Align software and hardware development priorities, timelines, and resources with clinical trials,
regulatory, and grant strategies.
• Oversee and manage design-controlled product development efforts including definition of proper and
testable product requirements, definition of product development milestones, conducting design
reviews, and rigorous testing & analysis in support of verification and validation activities.
• Identify potential collaborators for technology and product development efforts
• Provide reports and visibility to executive management

Other Tasks and Projects:
• Manage 3rd party vendors for software and relevant hardware services and equipment.
• As a startup, there is always a need to figure things out as they come up. Be prepared and willing to
jump in on time sensitive tasks as needed.
• Manage grant milestones and support grant report writing and new grant applications as applicable.

Required Qualifications
• PhD, MS, or BS in CS/EE or similar
• 8+ years medical device and/or healthcare software product development experience
• 5+ years software engineering management experience
• Experience taking software development projects from ideation through clinical deployment and
• Experience taking products from R&D into manufacturing and clinical deployment
• Leadership skills to effectively coach, mentor, and manage a technical group with broad responsibilities.
• Strong project management skills and ability to conceptualize ideas, motivate and focus individuals and
teams and drive projects through to completion on time and on budget.
• Medical Device industry experience. Prior history working in an FDA and/or ISO regulated development
environment; specifically, 21 CFR 820, IEC 62304, and ISO 13485
• High level of written and verbal communication skills.
• Ability to hire, mentor and develop talent for current and future needs and align talent decisions to
strategic plans.
• Demonstrated analytical, decision making, prioritization and problem-solving skills.

Preferred qualifications
• Experience in ultrasound, medical imaging, and/or complex electro-mechanical medical devices.
• Experience with development of complex electronic hardware and/or software applications deployed on
custom hardware.
• Experience with EMR/EHR integration and/or Cloud/SaaS products.
• Experience developing C++ software applications and strong software architecture expertise.
• Knowledge and experience in CI/CD systems and processes.

Requirements & Expectations
• Full-time role with flexible in-person requirements in Baltimore office.
• Applicants must be able to lift 35 lbs.