• Firmware Trace Engineer

    US Tech Solutions (Irvine, CA)


    Duration: 06 Months Contract

    About the Role:

    + We are seeking a skilled Firmware Engineer to join the Urology team. In this role, you will be part of the evaluation and integration of firmware on Urology medical device technologies. As a technical hands-on contributor, you will focus primarily on tracing software / firmware requirements from design inputs to design outputs, ensuring compliance with medical device regulations.

    + This role requires knowledge of medical device firmware design, IEC 62304 and 60601 standards, and attention to detail.

    Key Responsibilities

    + Be responsible for thorough tracing active implantable or external device software / firmware requirements to test evidence, and documenting this trace

    + Identifying and escalating any lack of clear trace evidence

    + Assist in identifying test strategies where needed

    + Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing and PMO

    + Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.

    Quality Systems Duties and Responsibilities:

    + Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

    Required Experience

    + B. S or M.S in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major.

    + B. S with 0 - 2+ years of experience in software development, ideally in embedded or application software for medical devices.

    + Strong technical writing skills

    + Sound knowledge of software engineering principles and practices.

    + Strong time management and communication skills.

    Preferred qualifications:

    + Experience at medical device manufacturer

    + Experience in active implantable medical devices

    + Working knowledge of IEC 60601 and/or 62304

    + Experience in Cognition Cockpit

    About US Tech Solutions:

    US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

     

    US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.