Principal Embedded Software Engineer

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.

Responsibilities:

• Collaboratively work with System’s 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, software driven electromechanical Class II medical devices; 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

Equal Opportunity Employer

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.

Reasonable Accommodations

The job summary, responsibilities and requirements listed above are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the responsibilities and skills required of this position. Reasonable accommodations may be made for any part of the application or interview process, and to enable qualified individuals with a medical condition or disability to perform the essential functions.