The Principal Software Engineer provides expertise in the design, development, characterization, and testing of complex software/firmware used to drive and manage complex electromechanical medical devices. In this role you will interface with a strong multidisciplinary team across the full product development life cycle including requirements, risk, implementation and testing activities. This position is full-time onsite in Waltham, MA.
Responsibilities:
- Collaboratively work with Systems Engineering to translate system level requirements into product architectures making tradeoff decisions regarding hardware and software partitioning
- 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
- Solve complex software issues by analyzing critical factors and recommending corrective or alternative actions
- Ensures adherence to company quality system, product specifications, industry standards, and quality and regulatory procedures and requirements
- Maintains accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methods
Requirements:
- Bachelor's Degree in Software or Electrical Engineering. Master's degree preferred.
- 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
- 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
- Strong analytical and leadership skills
