Senior Medical Systems Architect

3 weeks ago


Pleasanton, Kansas, United States Gateway Recruiting, INC. Full time

Job Overview

We are seeking an experienced systems engineer to join our team at Gateway Recruiting, INC. as a Senior Medical Systems Architect for our Heart Failure portfolio.

About the Opportunity

The ideal candidate will have 8+ years of experience in systems engineering and integration, system architecture, requirement/user need gathering, end-to-end technical product development, and system-level verification.

Responsibilities

  • Lead product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, System V&V, and design control documentation from design conception to launch.
  • Participate in and drive systems level decision making, accounting for and prioritizing critical needs and requirements and assessing various options and solutions.
  • Gather, assess, and analyze needs and input from stakeholders and translates to system architecture, definition, and requirements.
  • Lead the planning of system engineering tasks including timelines, budgets, and prioritization.
  • Perform system level characterization of devices through development to refine requirements and finalize the design for System V&V.
  • Collect, organize, analyze, document, and present results.
  • Plan, execute, and/or lead System V&V testing, data analysis, and documentation.
  • Communicate effectively to cross-functional teams and senior management.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications

  • Bachelor's Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or a related discipline.
  • 8+ years of experience in a similar position, including systems engineering and integration, system architecture, requirement/user need gathering, end-to-end technical product development, and system-level verification.

Preferred Qualifications

  • Advanced Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline.
  • Experience and expertise with systems consisting of hardware, software, mobile apps, and cloud components.
  • Experience and expertise with systems with RF, electromagnetics, ASICs, Bluetooth, and NFC technologies.
  • Class III implantable medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc).
  • Strong knowledge of a development process consistent with ISO, FDA design control standards or requirements, and risk management practices.
  • Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs.
  • Ability to work within a team and as an individual contributor and leader in a fast-paced, changing environment.

Salary Range: $120,000 - $180,000 per year


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