NIRSense is a cardiology company focused on developing world-leading non-invasive medical devices. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are a growing team of technology developers seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.
Job Summary:
The Software Engineering Manager will act as the people and technical lead for software across NIRSense's body-worn sensing devices, including embedded firmware, mobile and desktop applications, and the cloud backend. Key responsibilities include team management, project planning, and software lifecycle management under IEC 62304, with oversight of architecture, verification, release, and the implementation of algorithms developed by our biosensing scientists. The successful candidate will have shipped medical device software under IEC 62304 and knows how to keep a small team shipping compliant software reliably. This position will be located in Morrisville, NC and report directly to the Director of Operations.
Minimum Qualifications:
8+ years of professional software development experience, including 3+ years managing software or firmware engineers. Experience planning and executing concurrent software projects, including estimation and schedule management. Experience improving established development practices, including code review, continuous integration, automated testing, and release management. Software development experience in a regulated industry, medical device strongly preferred, with working knowledge of
IEC 62304, ISO
13485, and 21 CFR Part 820 design controls. Strong technical writing skills, including software plans, requirements, and verification records for the design history file. Hands-on embedded C/C++ experience on resource-constrained, battery-powered microcontrollers, including firmware bring-up on new hardware. Experience delivering BLE-connected devices with over-the-air updates, plus a companion mobile, desktop, or cloud application. B.S. in Computer Science, Computer Engineering, or a related field.
Preferred Qualifications:
Experience with Nordic nRF microcontrollers and Zephyr RTOS. Experience with iOS and Android development, or cloud backends handling protected health information under HIPAA. Experience with physiological signals (biophotonic, EEG, ECG, EMG), including porting algorithms from Python or MATLAB to production code. Experience with FDA 510(k) or De Novo software documentation, ISO 14971 risk management, and medical device cybersecurity. Startup experience, particularly in growing a software group.
Job Responsibilities:
Recruit, manage, and develop the software engineering team, and engage contractors as needed. Set team priorities and schedules, balancing new product development against sustaining and post-market support. Manage the software lifecycle under IEC 62304, and own the software content of the design history file and regulatory submissions. Partner with systems engineering, quality, and electrical engineering on risk management, cybersecurity, and hardware/firmware interfaces. Define the software architecture across firmware, applications, and cloud services. Oversee release management and field updates, and lead investigation of software issues from the field and complaints. Lead the production implementation of algorithms from the biosensing science team, and verify results against their reference implementations. Represent software engineering in audits and design reviews. Contribute to design and code, and review team code.
Salary:
The compensation package will be commensurate with the successful applicant's experience.
Hours:
Full-time Travel:
0-10% We are not working with any third-party vendors or on a C2C basis.
Please note:
This position is on-site in Morrisville, NC. This role cannot be remote. NIRSense is unable to provide current or future employment visa sponsorship for this position. Candidates must be authorized to work in the United States without employer sponsorship.
