Staff Software Engineer

Develop within a regulated software development lifecycle: IEC 62304 process requirements and FDA human-factors/usability expectations, with design decisions and validation evidence documented for audit readiness.

Produce the software lifecycle and human-factors documentation (requirements, architecture, verification, usability evidence) that feeds the design history file and our FDA submissions.

Ensure the applications support regulatory audit trails and clinical-trial documentation.

Partner with our medical teams to deeply understand how clinicians and patients will actually use the system, and turn that insight into application design decisions.

Direct external contributors on non-core modules, maintaining compliance, accessibility, and integration quality.

Qualifications

Bachelor’s degree in Computer Science or related field, or equivalent practical experience.

7+ years of software engineering experience, with substantial time in healthcare or FDA-regulated medical-device software.

Production experience shipping Android applications in Kotlin (native) or React Native, delivering features end to end.

Experience developing software under IEC 62304 (or an equivalent risk-based lifecycle) for Class B or higher software, including lifecycle documentation supporting regulatory submissions.

Experience building responsive mobile interfaces over high-frequency or time-series data; comfortable with streaming and device connectivity.

Experience designing app features against backend/cloud APIs; able to consume and document API contracts.

Track record translating clinician or patient feedback into design; effective with non-technical stakeholders.

Preferred Qualifications

Software and/or usability documentation contributed to an FDA submission (IDE, 510(k), or PMA).

Clinical-trial software experience; familiarity with 21 CFR Part 11 or trial data-management systems.

Experience with a medical-grade device-management platform.

Human factors / usability engineering; familiarity with FDA guidance on medical-device UX.

Accessibility compliance (WCAG 2.1, medical-device accessibility standards).

Secure-SDLC awareness (e.g., IEC 81001-5-1).

Physical Requirements

Ability to work on site, including hands-on testing with prototype devices and participation in bench and integration sessions.

Benefits

Full-time employees are eligible for the following benefits listed below.

Competitive base salary with equity

100% of healthcare coverage for you and your dependents

Generous vacation policy

Paid parental leave

Work from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.