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Lenexa

    Systems Architect Engineer - Lenexa, United States - Sterling Medical Devices

    Sterling Medical Devices
    Sterling Medical Devices Lenexa, United States

    2 weeks ago

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    Description


    From high-level product requirements to architecture conceptualization and detailed safety analyses, the Systems Engineer will collaborate with software, electrical, mechanical, quality and test engineers to bring our clients' medical devices from design concept to commercialization.

    Our Company's medical products improve quality of life for patients every day. Our innovative products are developed by experienced, multi-disciplinary teams and require a high level of hardware and software integration.

    We are adding a Systems Engineer to our 40+ engineering team to support the growth of our vast portfolio of medical devices.

    This role requires communication to ensure feedback between customers, internal and external engineering teams that are both local and remote team members.


    Responsibilities:


    Lead technical success of engineering Team in all stages of new product development from requirements management and system architecture to product commercialization.

    Primary technical contact for both client and internal team members; Highly engaged with client's technical experts, clinicians, and marketing.
    Drive a sense of urgency, product excellence and innovation to ensure project success.

    Coordinate closely with a broader team of engineers including electrical, software, mechanical, and testto resolve multi-discipline issues and develop compelling medical devices.

    Manage and lead resolution of systems engineering issues including architecture, hardware, and software design tradeoffs.
    Apply engineering theory, methods, and techniques to overcome technical and process related challenges in product development.
    Collaborate with Project Managers to develop proposals, lead the development team and produce designs that fulfill client vision.


    Qualifications:
    BS degree in Software, Electrical, Mechanical or Biomedical Engineering.
    3+ years' experience in Systems Engineering for electromechanical and embedded systems product development.
    Experience with customized embedded electronics and software (this is not an information technology role).
    Demonstrated understanding of Systems Engineering tools and principles as applied to electromechanical and embedded systems (hardware and software) products.
    Ability to exercise sound judgment and make risk-based decisions to advance product development in a timely manner.
    Experience with high-level design including system level architecture, design tradeoffs and constraints.
    Experience developing technical requirements and risk management.
    Demonstrated project leadership skills.
    Excellent communication, interpersonal andproblem-solving skills.

    Experience with FDA class II or III medical device regulatory requirements, or experience in similar regulated product development environment is a plus.

    We offer great benefits, competitive salary, and generous paid time off.
    We are a cutting-edgemedicaldevice design firm located in theKansas City metropolitan area.
    We partner with OEM companies worldwide to design and manufacture life-saving medical devices to be sold into thehealthcare marketplace.

    Our culture is innovative, supportive, and focused on delivering the best medical device design and manufacturing services to their clients world-wide.

    Our project list continues to grow and evolve into new therapeutic areas every year.

    In 2024we will be developing new products for the treatment of:

    Heart Failure
    Cancer
    Stroke
    Gene Therapy

    COPD
    Traumatic Brain Injury
    Atrial Fibrillation
    Rhinitis
    Back and Neck Pain
    Blood Clots
    Brain Surgery

    • More


    We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide.

    If this is something you aspire to, we would like to talk with you

    Our Company values a diverse team and is an Equal Opportunity Employer.

    We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law.

    All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States. For more information, .

    Local candidates only at this time, please. We do not offer relocation assistance.
    No third-party candidates please.

    Have you been responsible for a detailed design and implementation of a commercially produced product?
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