Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.
To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.
Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.
As the Head of Embedded Systems Engineering, you will play a leadership role in:
- Leading the development of our next generation of FDA cleared non-invasive monitoring devices
- Working cross-functionally with engineering, quality, regulatory, marketing, and management teams to align project schedules, drive product delivery, and maintain regulatory standards compliance
- Driving documentation, verification testing, risk analysis, and design processes needed for medical device products
- Lead development of medical device solutions that include hardware devices, mobile devices, web interfaces, and cloud backend. Work closely with the current team to develop system requirements, architecture and design, and integration of hardware and software
- Document all phases of product development to include in a design history file including user needs assessment, design inputs, design outputs, verification, validation, and risk management
- Take ownership of project timelines and ensuring the cross functional resources are in place to deliver high quality products on schedule
- Interface with software developers to aid in the integration of software system solutions
- Define and illustrate system architecture, describes interfaces between sub-systems, and drive system architecture updates between releases
- Drive decision making related to product development, including firmware architecture, PCB design, wireless communications, and user interfaces
- Mentor and coach junior engineers
- BS/MS in Electrical Engineering, Biomedical Engineering, or equivalent field
- 8+ years of experience in embedded systems product development (medical device experience highly preferred)
- Exposure to medical device standards and regulatory processes, including 21 CFR 820, ISO 13485, IEC 62304, and IEC 60601
- Strong understanding of cloud architecture and IoT devices, both hardware and firmware
- Experience working with external vendors and consultants
- Demonstrated experience leading and managing small teams
- Proven history of developing and deploying embedded PCB designs with wireless communication to production
- Experience overseeing external vendors and consultants