• USA - Sr. Principal Engineer

    Robert Half Technology (Bellevue, WA)


    Description

    Join a high-impact team driving innovation in medical device development—where your expertise in software and hardware quality engineering will directly shape the future of healthcare technology.

    Schedule & Location:

    + Hours: 8:00 AM – 5:00 PM (Pacific Time)

    + Work Setup: Hybrid preferred (3 days/week onsite or as needed)

    + Local candidates preferred

    + Open to remote with occasional travel to site

    Employment Type:

    + Contract with possibility of extension

    + Temp-to-hire potential

    Job Description

    Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with regulatory standards and driving quality throughout the product lifecycle.

     

    Essential Duties & Responsibilities

    Primary Responsibilities:

    + Lead design control, risk management, and other quality engineering activities for new product development.

    + Develop and maintain Risk Management Files (RMF): risk plans, hazard analysis, dFMEAs, pFMEAs, and reports.

    + Review and approve Design History File (DHF) documentation.

    + Oversee product development plans, design inputs/outputs, verification/validation, and test protocols/reports.

    + Guide statistical methods and analyses for design verification and validation.

    + Act as SME for software quality: code reviews, software security analysis, software BOM, and best practices.

    + Participate in design reviews for hardware/software lifecycle management.

    + Support production transfer and post-deployment phases.

    + Address anomalies (e.g., bugs, cybersecurity issues) and guide remediation.

    Secondary/Backup Responsibilities:

    + Lead updates to the Quality System based on new regulations and standards.

    + Own CAPA resolution related to design control.

    + Support released products and interface with customer support.

    + Assist other Quality System areas as needed.

    Requirements

    Qualifications

    Required:

    + 8+ years of progressive Quality Engineering experience in the medical device industry.

    + Hands-on support for hardware and software development.

    + Strong knowledge of:

    + FDA CFR 820

    + ISO 13485, ISO 14971

    + IEC 60601 series, IEC 62304, IEC 62366

    + Experience with:

    + Design, development, verification, validation, and testing of medical devices

    + Statistical tools and data analysis

    + Excellent communication and presentation skills

    + Ability to manage multiple projects and advocate for quality

    + Proficient in Microsoft Office, Adobe Acrobat, Minitab, and other business software

    Preferred:

    + ASQ CQE certification and/or Six Sigma Black Belt/Green Belt

    + Experience with:

    + Artificial Intelligence (AI) and AAMI TIR45 framework

    + Software as a Medical Device (SaMD)

    + Cloud infrastructure

    Education:

    + B.S./M.S. in Engineering (Biomedical, Software, Electrical, etc.) or equivalent scientific degree

     

    Technology Doesn't Change the World, People Do.®

     

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    All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

     

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