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Come join UltraSight- AI Powered Cardiac Ultrasound!

About UltraSight

UltraSight is a medical technology company developing AI-powered solutions designed to make cardiac ultrasound more accessible and easier to use. Our multidisciplinary team combines software engineering, artificial intelligence, clinical expertise, product development, and medical-device quality and regulatory practices.

About the Role

We are looking for a hands-on, technically strong System Engineer who can see both the details and the bigger picture. The right candidate will be comfortable moving between specifications, architecture, integration, release documentation, troubleshooting, and cross-functional discussions, while helping ensure that UltraSight's products are robust, well-defined, traceable, and developed in accordance with medical-device development and quality processes.

The System Engineer will work across multiple disciplines and serve as a technical bridge between R&D, Product, Quality, and Development teams. The role includes translating product and clinical needs into clear system specifications, defining system behavior and interfaces, supporting architectural decisions, and ensuring that specifications are properly implemented, verified, and traced throughout the product lifecycle.

This position is well suited for someone who enjoys understanding the complete system, working across software, algorithms, external devices, and cloud components, and bringing structure to complex multidisciplinary products.

• Own and maintain system-level specifications and technical documentation for UltraSight products.
• Translate product, clinical, business, regulatory, and user needs into clear and testable system specifications.
• Define system architecture, interfaces, data flows, workflows, and interactions between product components.
• Work closely with software developers, algorithm teams, Product, Quality, and other stakeholders throughout the development lifecycle.
• Lead and participate in system design reviews and technical discussions.
• Ensure consistency and traceability between user needs, system specifications, software specifications, design outputs, risk controls, and verification activities.
• Support specification analysis, impact analysis, and change management for new features and product changes.
• Define interfaces with external systems and devices, including ultrasound systems, mobile devices, cloud services, hospital IT systems, and other integrated technologies.
• Support system integration activities and troubleshooting of complex issues involving multiple system components.
• Work with Quality and R&D teams to support risk-management activities, including identification of system-level hazards, mitigations, and verification of risk controls.
• Support verification and validation planning by defining acceptance criteria and ensuring specifications are measurable and testable.
• Participate in investigation of field issues, product anomalies, and root-cause analysis.
• Prepare and maintain technical product release documentation, ensuring that design outputs, verification evidence, known issues, and released configurations are properly documented.
• Support the creation, organization, and ongoing maintenance of Design History File (DHF) documentation throughout the product lifecycle.
• Contribute to technical documentation required for medical-device development, regulatory submissions, audits, and product changes.
• Help improve system-engineering methodologies, documentation, tools, and processes within the R&D organization.

Qualifications

• B.Sc. in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, Systems Engineering, or a related technical field.
• 3+ years of experience in system engineering, software engineering, technical product development, or a similar multidisciplinary engineering role.
• Experience in medical-device or medical-software development.
• Familiarity with medical-device development processes and standards, including IEC 62304, ISO 14971, and ISO 13485.
• Experience with design controls, specifications, traceability, verification and validation, risk management, and technical documentation.
• Strong ability to understand complex systems and break them down into clear components, interfaces, specifications, and workflows.
• Experience writing technical specifications, system documentation, and design documentation.
• Strong analytical and problem-solving skills.
• Ability to work effectively with multiple disciplines and communicate technical subjects clearly to both technical and non-technical stakeholders.
• Experience working closely with software development teams.
• Excellent written and verbal communication skills in English.

Strongly Preferred Qualifications

• Experience with mobile applications, cloud-based systems, AI/ML-based products, or image-processing systems.
• Familiarity with medical imaging, ultrasound, DICOM, PACS, or hospital IT environments.
• Experience integrating software with external hardware or third-party systems.
• Experience supporting product releases, regulatory submissions, audits, or post market product changes.
• Experience effectively utilizing AI assistants and agent-based tools such as ChatGPT, Claude, or similar platforms to support technical analysis, documentation, research, specification development, troubleshooting, and engineering workflows.

EQUAL OPPORTUNITY EMPLOYER

Connecticut Innovations and its portfolio companies are an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We have strict wage minimums, generous benefits, and personal leave policies. Our goal is to provide safe, rewarding, and empowering work environments for all who interact with our company and/or portfolio companies.