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Sr. Systems Engineer

  • Specialty:

  • Title:

    Sr. Systems Engineer
    • City:

      New York
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  • Start date:

  • Status:

  • Assignment Type:

    Direct Hire
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Do you know a Systems Engineer with a passion for developing cutting edge medical device products that transform and save lives? World leader in surgical innovation is expanding and poised to hire a talented Systems Engineer with experience across all stages of product development. If this sounds like you or someone you know, that person should apply to this posting with their resume today!

Position Description
As we build our team there is a Senior Systems Engineer role for an individual with medical device product development experience. This position would operate within Surgical Innovations.

SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

A Day in the Life

  • You will work and lead within a cross-functional team to design, develop, test, and document innovative system solutions utilizing opto-electro-mechanical and fluidic system components.
  • You will lead the definition and development of user needs, business needs, use cases, requirements, and system architecture.
  • You will lead the engineering analysis to optimize and select system-level concepts to ensure the final solution fulfills needs, requirements, use cases, environments, and the overall system vision.
  • You will serve as a technical consulting resource for integration, system verification activities, creating plans, protocols and reports as necessary.
  • You will lead the team in identifying and mitigating technical risks, product hazards, and failure modes.
  • You will influence strategic direction around design practice and processes.

Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

  • Domain expertise in one of more engineering disciplines (preferably in electrical engineering, mechanical engineering, or computer science).
  • Experience with architecting electro-mechanical systems including microprocessor-controlled electronics, embedded software, and advanced motor control.
  • Experience establishing multi-level requirement strategy and generating requirements that meet industry best practices.
  • Experience and capability working collaboratively under a Quality Management System, as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory, and quality engineering experts.
  • Experience working in a regulated environment.
  • Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Polarion ALM, Arena PLM, DOORS Next).
  • Ability to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues.
  • Excellent communication skills, verbal, written and non-verbal.
  • Advanced technical degree.
  • Formal training in systems engineering concepts.
  • Understanding of systems engineering practices such as requirements management, risk analyses, design trade-off and cost-benefit analysis.
  • Understanding of the principles and methodologies from the Systems Engineer Competency Framework developed by International Council of Systems Engineering.
  • Experience with model-based systems engineering.
  • Experience with electro-mechanical and software integration.
  • Experience with endoscopic visualization devices.
  • Experience with long term R&D development programs (concept, feasibility, development, commercialization).
  • Experience in Women’s Health and ability to interact with clinicians in their environment.
  • Demonstrated skills in developing and introducing innovative FDA-regulated medical devices to market; experience with medical device regulations (ISO 13485, IEC 62304, IEC 60601, ISO 14971, 21 CFR part 820.30-Design Controls).
  • Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.
  • Experience with coding and software tools (C++, Java, Android Studio, MATLAB).
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 

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