Third Pole is looking to expand the lifesaving benefits of Nitric Oxide inhalation therapy, making it accessible to millions of respiratory challenged newborns and adults around the world by developing a game-changing technology that generates Nitric Oxide on demand.
Requirements
- 10+ years Software Engineering experience in the design and development of complex, real time software driven electromechanical Class II medical devices in C and C++; Class III experience preferred
- Detailed knowledge of key regulatory requirements included ISO 13485, ISO 14971, ISO 62304 as well as FDA QSR 21 CFR Part 820
- Recent microcontroller experience
- Experience with electronic design control and document management systems preferred
- design, development, characterization, and testing of complex software/firmware used to drive and manage complex electromechanical medical devices
- Uses modeling, hardware-in-the-loop simulation and actual devices to develop, debug and test complex systems
- Develop software subsystem architectures aligned to product level requirements and architectures including software requirements definitions and sub-system designs
Responsibilities
- Uses modeling, hardware-in-the-loop simulation and actual devices to develop, debug and test complex systems to meet required performance
- Develop software subsystem architectures aligned to product level requirements and architectures including software requirements definitions and sub-system designs
- Design and develop software/firmware utilizing C and C++ on embedded real time operating systems (RTOS) following company and industry requirements and best practices
- Performs advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify solutions
- Perform software verification including code reviews, writing unit test cases, and running static analysis
- Document system design inputs and outputs using the Third Pole's design control and document management system
- Evaluates product performance on an on-going basis and initiates and evaluates required changes to the designs to improve and optimize performance
Other
- This position is full-time onsite in Waltham, MA.
- Ability to work independently with high competency and little guidance.
- Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems
- Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency
- Strong design control and documentation skills
