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.
Cardiosense is seeking a Senior Embedded Systems Engineer to drive development of our fully connected, wearable device that will allow us to get through regulatory requirements and onto patients.
As a Senior Systems Engineer, you'll lead the design and execution of a technical strategy to develop, test, and validate this next-generation FDA-cleared device. You'll work with internal and external teams to align project schedules, drive product delivery, and maintain regulatory standards compliance.
What you will do:
- Lead development of our medical device solution. Work closely with the current team and contractors to develop system requirements, architecture and design, and integration of hardware and software.
- Define and illustrate system architecture including interfaces between sub-systems, and drive system architecture updates between releases
- Drive completion of design history file including user needs assessment, design inputs, design outputs, verification, validation, and risk management
- Drive decision making related to product development, including firmware architecture, PCB design, wireless communications, and user interfaces
- Support engineering efforts where needed help to drive projects to completion
- Interface with software developers to aid in the integration of software system solutions
- BS in Electrical Engineering, Systems Engineering, Biomedical Engineering, or equivalent field.
- 5+ years of experience in embedded systems product development (medical device experience highly preferred)
- Exposure to medical regulatory processes, including 21 CFR 820, ISO 9000, ISO 13485, and IEC 60601.
- Strong understanding of IoT devices, both hardware and firmware.
- Experience with product development methodologies including Scrum/Agile.
- Ability to contribute to product design and development, particularly with mechanical and analog design.
- Experience overseeing external vendors and consultant.