Principal Embedded Software Engineer
Third Pole, Inc.1 year ago
Waltham, MA, USAStaff+
Responsibilities
- Translate system-level requirements into product architectures and make hardware-software partitioning tradeoffs with Systems Engineering.
- Use modeling, hardware-in-the-loop simulation, and actual devices to develop, debug, and test complex systems.
- Develop software subsystem architectures, software requirements definitions, and subsystem designs.
- Design and develop C and C++ software and firmware on embedded real-time operating systems.
- Perform advanced risk analyses using FMEA and fault tree methods and collaborate across engineering disciplines to verify solutions.
- Perform software verification through code reviews, unit testing, and static analysis.
- Document system design inputs and outputs using the company’s design control and document management system.
- Evaluate product performance and initiate design changes to improve and optimize performance.
- Analyze complex software issues and recommend corrective or alternative actions.
- Ensure adherence to quality systems, product specifications, industry standards, and regulatory procedures.
- Maintain accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methods.
Requirements
- Bachelor’s degree in Software or Electrical Engineering is required; a master’s degree is preferred.
- 10+ years of software engineering experience designing and developing complex real-time software-driven electromechanical Class II medical devices using C and C++; Class III experience is preferred.
- Detailed knowledge of ISO 13485, ISO 14971, ISO 62304, and FDA QSR 21 CFR Part 820 is required.
- Recent microcontroller experience is required.
- Experience with electronic design control and document management systems is preferred.
- Ability to work independently with high competency and little guidance.
- Creative problem-solving ability and capacity to develop novel solutions to complex problems.
- Ability to work effectively in a fast-paced, high-energy, collaborative team.
- Strong design control, documentation, analytical, and leadership skills.
Benefits
- Full-time onsite position in Waltham, Massachusetts.
About Third Pole, Inc.
Third Pole, Inc. develops cardiopulmonary therapies centered on a compact medical device that generates inhaled nitric oxide from ambient air on demand, eliminating the need for large gas cylinders. The privately held company, based in Waltham, Massachusetts, targets hospitals and other care settings treating newborns and adults with respiratory or pulmonary hypertension needs, and seeks to extend nitric‑oxide therapy beyond acute care through portable systems.