Talent.com
Systems Engineer

Systems Engineer

EntegeeMinneapolis, Minnesota
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Summary : Seeking an experienced Systems Engineer with expertise in design, verification, and validation for medical devices.

Requirements :

  • Bachelor's degree in Engineering
  • Minimum 2 years of experience in system design and V&V within the medical device industry
  • Experience with system architecture and design for all phases of development
  • Ability to collect and analyze design inputs and transform them into engineering requirements
  • Experience performing functional analysis, timeline analysis, and trade studies
  • Familiarity with hardware, firmware, and communication interfaces
  • Experience developing sensor-based systems and closed-loop feedback control systems
  • Knowledge of ISO and Quality System Regulation requirements, including IEC-60601, IEC-62304, ISO-14971, and FDA 21CFR820.30
  • Experience in Product Risk Assessment and Risk Management
  • Experience in troubleshooting firmware / software interfaces

Preferred Skills :

  • Experience developing data analytics and machine learning algorithms
  • Previous medical device experience with product development from concept to market release
  • Experience interfacing with physician customers and therapy consultants
  • Experience working in FDA-regulated environments

    • Responsibilities :

  • Perform system architecture and design for all phases of system development
  • Ensure system requirements are properly implemented through inspection, demonstration, testing, or analysis
  • Lead system analysis and design activities, including architecture definition, interface management, and performance modeling
  • Identify technical development risks and execute risk burn-down plans
  • Facilitate cross-functional communication to drive design decisions and review test results
  • Support regulatory submissions and facilitate knowledge transfer to continuation engineering teams
  • Manage moderately complex projects, including delegating tasks and reviewing work products
  • Establish and advocate for best practices to improve Systems Engineering processes
  • Participate in the development of system and product roadmaps

    • Pay Details : $49.00 to $66.00 per hour

    Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

    Equal Opportunity Employer / Veterans / Disabled

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  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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    System Engineer • Minneapolis, Minnesota