Dopl Technologies is redefining access to healthcare through remote robotic care delivery by combining robotics, AI, and spatial computing to address clinician shortages and burnout while ensuring timely access to diagnostic and interventional care. The company is seeking a Software Engineer to contribute to the development of next-generation telerobotic ultrasound systems, ensuring regulatory submission readiness.
Requirements
- Experience developing software for medical devices or products in other regulated industries.
- Proficiency in one or more programming languages (e.g., C++, Python, or NodeJS).
- Working knowledge and practical understanding of software development life cycle (SDLC) and medical device regulatory standards, including IEC 62304, ISO 13485, and ISO 14971.
- Experience with cloud-connected or mobile medical devices.
- Familiarity with cybersecurity and data privacy requirements for medical software, including threat modeling and secure communication.
- Knowledge of usability engineering per IEC 62366 and FDA cybersecurity guidance.
Responsibilities
- Design, develop, and maintain software for medical devices and supporting systems.
- Collaborate with cross-functional teams, including hardware, quality, regulatory, and clinical teams, to ensure product safety and compliance.
- Lead or participate in software design reviews, code reviews, and formal risk assessments. Ensure design outputs meet traceability expectations.
- Ensure the system complies with relevant standards, such as IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820, the Quality Management System Regulation (QMSR).
- Support verification and validation planning and execution, including unit, integration, and system-level testing.
- Create and maintain software documentation required for regulatory submissions, including software specifications, test plans, and design history file content.
- Troubleshoot and resolve software issues to improve performance and reliability.
Other
- This is a hybrid role with regular onsite collaboration in Bellevue, WA.
- Strong analytical, documentation, and problem-solving skills.
- Excellent communication and teamwork abilities.
- Collaboration across teams and occasional travel to testing sites or manufacturing partners may be required.
- Mission-driven builders who are passionate about technology that matters.
