Company
 
Cardiosense is a medical technology startup that operates at the
intersection of wearable technology and artificial intelligence to improve
patient health. Our mission is to use physiological data to predict cardiac
illness and enable early interventions so people can enjoy healthier, longer
lives.
 
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 monitoring
solutions.

Description

As a Senior Systems Engineer, you will play a role in:

  • Designing and leading implementation of a technical strategy to develop, test, and validate our next generation of FDA cleared devices.
  • Work cross-functionally with engineering, quality, regulatory, marketing, and management teams to align project schedules, drive product delivery, and maintain regulatory standards compliance.
  • Leading documentation and compliance testing for class II medical devices.

Responsibilities

  • Support systems engineering efforts to a medical device solution that includes hardware devices, mobile devices, web interfaces, and cloud backend.
  • Work closely with the current team to develop system requirements, architecture and design, integration of hardware and software, and validation and verification. 
  • Document all phases of product development to include in a design history file including user needs assessment, design inputs, design outputs, validation and verification. 
  • Support device and software architecture design by developing, documenting and maintaining product specifications.
  • 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.
  • Assist with product development, including firmware architecture, analog design, wireless communications, and user interface.
  • Mentor and coach junior engineers.

Qualifications

  • BS in Electrical Engineering, Systems Engineering, Biomedical Engineering, Mechanical Engineering or equivalent field.
  • 8+ years of experience in systems engineering in product development.
  • Exposure to medical regulatory processes, including 21 CFR 820, ISO 9000, ISO 13485, and IEC 60601.
  • Strong understanding of cloud architecture and 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. 

 

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