Company Summary:
410 Medical, based in Durham, NC, is focused on innovative technology to improve resuscitation of critically ill patients. 410’s lead product, LifeFlow, is designed to enable clinicians to more effectively and efficiently deliver blood and fluids to patients with shock and sepsis in urgent need of rapid resuscitation. LifeFlow was first cleared by the FDA in 2016 and is currently being marketed in the United States.
Position Summary:
The Embedded Systems Engineer will be responsible for ideation, design, troubleshooting, verification, and validation of embedded systems in 410 Medical’s new development projects. This position will report to the Principal R&D Engineer and will work closely with external vendors, consultants, and customers as well as the 410 Medical team.
The specific roles and responsibilities include those listed below.
Duties and Responsibilities:
Serve as a key contributor to 410 Medical’s next generation platform in electronics, software, and embedded systems.
Work with 410 Medical’s internal team and external engineering partners to develop, troubleshoot, verify, and validate embedded systems.
Develop, document, test, and validate critical medical device firmware.
Participate in compliance activities for qualifying electronic medical devices under standards including IEC60601-1, IEC62304, and others.
Test and troubleshoot new and existing electrical designs.
Manage electrical and firmware work of external partners.
Participate in, document, and lead design reviews related to electrical systems and firmware.
Generate medical device design control documents including verification and validation test protocols and reports, FMEA, BOMs, component specifications, technical drawings, and other documentation related to electrical systems and firmware.
Perform root cause analyses, propose and implement effective solutions.
Manage third-party standards testing for standards mentioned above.
Skills/ Qualifications:
BS or MS in Electrical Engineering, Computer Science, or Biomedical Engineering and 5+ years related experience
Strong background in engineering with documented experience in designing embedded systems for devices. Medical device experience is a plus.
Experience with the following
Development of electrical system architecture
Schematic design, board layout, and troubleshooting of electrical circuits
Custom PCB design, component specification
Firmware development, debugging
Battery and power system design
Experience writing embedded device firmware for ARM based MCUs
Experience writing code using C, Python is nice to have, but not required
Experience operating under a formal design control system and maintaining a design history file
Demonstrated leadership and project management skills
Strong communication skills, ability to convey ideas in a clear, concise manner
Other Requirements and Details:
Full-time role based in Durham, NC
Limited travel involved; less than 10% travel to hospitals/EMS/Military or conferences
Must be able to meet credentialing requirements in order to observe product use within a hospital, EMS, or military environment
410 Medical is an equal opportunity employer. As such, we provide employment opportunities without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, military service, or other characteristics protected by law.