Staff Systems Engineer

G

Gateway Recruiting

Staff Systems Engineer

Portland, OR
Full Time
Paid
  • Responsibilities

    This role will lead and support critical efforts across product feature scoping, system architecture, design, and integration—both within the next-generation, miniaturized Cardiac Rhythm Management (CRM) devices and across broader, platform-level technology development initiatives.

    The Staff Systems Engineer will engage across the full product lifecycle—from early concept work to formal project initiation, and through verification and validation. Success in this role requires strong technical expertise, sound critical thinking, and excellent communication skills. This role will also need a proven ability to collaborate effectively with a variety of technical, end-user, and business-oriented stakeholders.

     

    Responsibilities:

    • BS Degree in an engineering discipline or related technical and/or life-science field
    • Familiarity/comfort with Systems Engineering work in accordance with ISO/IEC/IEEE 15288 [Note: we are NOT seeking IT Systems Administrators/Engineers]
    • 3-5 (or more) years’ experience in the medical device (or similarly-regulated – e.g., aerospace) industry
    • Demonstrable success in supporting one or more strategic, multi-faceted projects to completion
    • Familiarity/comfort with issue management (per ISO 14971 and IEC 62304 for those with medical device backgrounds), in service of development work bug documentation/dispositioning
    • Baseline computer programming skills, inclusive of the ability to review embedded software, digital logic, and hardware description language (HDL)

     

    Qualifications:

    • BS Degree in an engineering discipline or related technical and/or life-science field
    • 5+ years of experience as a Systems engineer working in accordance with ISO/IEC/IEEE 15288 [Note: Stated explicitly, we are NOT seeking IT Systems Administrators/Engineers]
    • 3+ years of experience in the medical device (or similarly-regulated – e.g., aerospace) industry
    • Demonstrable success in driving one or more strategic, multi-faceted projects to completion
    • Experience with issue management (per ISO 14971 and IEC 62304 for those with medical device backgrounds), in the service of development work bug documentation/dispositioning
    • Baseline computer programming skills, inclusive of the ability to review embedded software, digital logic, and hardware description language (HDL)

     

    Additional Preferred Knowledge, Skills, Abilities:

    • Degrees in electrical and/or systems engineering (especially Masters-level) are generally preferred
    • Experience in active CRM therapy product development, especially with miniaturized device types
    • Versed on International Council on Systems Engineering (INCOSE) best practices
    • System simulation experience (e.g., SysML, Python/MATLAB, ANSYS, AMD Vivado [formerly Xilinx], etc.)
    • Familiarity with international standards relevant to product realization in the Class III medical product space especially regarding relevant system requirements interfacing strategies
    • Previous experience in supporting taskforce investigational initiatives (e.g., working on “tiger teams”)
    • Versed on the Usability process as outlined in IEC 62366-1