Principal Embedded Software Engineer
Location
Indiana | United States
Job description
Principal Embedded Software Engineer Location Hybrid remote in Waltham, MA :
Our client is on a mission to expand the lifesaving benefits of Nitric Oxide inhalation therapy, making itaccessible to millions of respiratory challenged newborns and adults around the world. This is a rareopportunity to be part of a rapidly growing team, making a huge social impact, touching the lives ofthose we love and care about most.We are a fast-paced startup developing a game-changing technology that generates Nitric Oxide ondemand, at the patient location, from the air we breathe. Our community is grounded in thevalues of collaboration, embracing diverse ideas, commitment, and transparency without the politicsfound 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, andtesting of complex software/firmware used to drive and manage complex electromechanical medicaldevices. In this role you will interface with a strong multidisciplinary team across the full productdevelopment 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.
- Minimum of 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
Job Type: Full-time
Pay: $140,000.00 - $185,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Education:
Experience:
- Embedded software: 10 years (Preferred)
- Software Engineering: 10 years (Preferred)
- Class 2 or 3 Medical Device: 6 years (Preferred)
- ISO regulations: 10 years (Preferred)
Ability to Relocate:
- Waltham, MA 02452: Relocate before starting work (Required)
Work Location: Hybrid remote in Waltham, MA 02452
Job tags
Salary
