Bachelor's degree in Software or Electrical Engineering; Master's preferred.
10+ years in Software Engineering for complex, real-time software driven medical devices, preferably Class II or Class III.
In-depth knowledge of ISO 13485, ISO 14971, ISO 62304, and FDA QSR 21 CFR Part 820 regulatory requirements.
Recent experience with microcontrollers.
Preferred experience with electronic design control and document management systems.
Ability to work independently with minimal guidance.
Creative problem-solving skills for complex challenges.
Capacity to thrive in a fast-paced, collaborative team environment.
Responsibilities
Collaborate with Systems Engineering to transform system requirements into product architectures and make tradeoff decisions.
Use modeling and hardware-in-the-loop simulation to develop and test complex systems for performance validity.
Develop software architectures aligned with product level requirements and document designs.
Design and write software/firmware in C and C++ on embedded RTOS following best practices and company standards.
Conduct advanced risk analyses and collaborate with engineering teams to verify effective solutions.
Perform software verification tasks including code reviews, unit tests, and static analysis.
Document system design processes in compliance with Third Pole's management system.
Benefits
Be part of a mission-driven company focused on impactful healthcare solutions.
Collaboration-focused culture without corporate politics.
Opportunity to work in a rapidly growing startup environment.
Direct involvement in transforming medical device technology.
Onsite position fostering team interaction and rapid project execution.
Full Job Description
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
