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    Principal Embedded Software Engineer - Waltham, United States - InnoTech Staffing

    InnoTech Staffing
    InnoTech Staffing Waltham, United States

    2 days ago

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    Description

    Job Description

    Job Description

    InnoTECH Staffing is looking to hire a Principal Embedded Software Engineer for a well funded and growing late stage medical device start-up in Waltham, MA.

    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 company'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
    This role requires being onsite 5 days a week in Waltham.

    Compensation includes base salary, bonus, equity, and full benefits.
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