Software Engineering Manager

NIRSense Inc. • Durham, NC

6d • Onsite

About The Position

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.

Requirements

• 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.
• Must be authorized to work in the United States without employer sponsorship.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager