Principal Embedded Software Engineer

Third Pole Therapeutics; Waltham (MA); Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

Third Pole Therapeutics is seeking a Principal Software Engineer in Waltham, MA to lead complex software development for electromechanical medical devices. You will collaborate with interdisciplinary teams, develop real-time software in C and C++, and ensure compliance with regulatory standards.

The ideal candidate will have 10+ years of experience and a strong ability to solve complex problems creatively. This role is essential in advancing innovative nitric oxide therapy technology.

Qualifications

• 10+ years of experience in Software Engineering for Class II medical devices.
• Detailed knowledge of ISO 13485, ISO 14971, ISO 62304, FDA QSR.

Responsabilités

• Translate system level requirements into product architectures.
• Develop and test software for electromechanical medical devices.
• Perform software verification and design control documentation.

Connaissances

C and C++

Embedded real-time operating systems

Risk analysis (FMEA, fault tree)

Software verification (code reviews, unit tests)

Formation

Bachelor’s Degree in Software or Electrical Engineering

Master’s degree

Outils

Document management systems

Modeling tools

Description du poste

Third Pole is on a mission to expand the lifesaving benefits of Nitric Oxide inhalation therapy, making it accessible to millions of respiratory challenged newborns and adults around the world. This is a rare opportunity to be part of a rapidly growing team, making a huge social impact, touching the lives of those we love and care about most.

We are a fast-paced startup developing a game-changing technology that generates Nitric Oxide on demand, at the patient location, from the air we breathe. Our Third Pole community is grounded in the values of collaboration, embracing diverse ideas, commitment, and transparency without the politics found in most companies. Our motto is we are only successful if we all cross the finish line together! Sound like you?

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
• Evaluate 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
• 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

Third Pole, Inc. provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.