Systems Engineer - Medical Devices Job at Global Connect Technologies, Milwaukee, WI

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  • Global Connect Technologies
  • Milwaukee, WI

Job Description

Job Title: System Engineer – Medical Devices

Location: Milwaukee, WI

Employment Type: Full-Time

About the Role:

We are seeking a talented System Engineer to support the design, integration, and lifecycle management of medical devices and healthcare technology solutions. This role involves working closely with cross-functional teams to ensure safety, reliability, regulatory compliance, and high-quality product performance.

Key Responsibilities

  • Lead system-level requirements definition, decomposition, and traceability.
  • Develop system architecture, interfaces, and integration plans across hardware, software, and electronics.
  • Support risk management activities (FMEA, hazard analysis, usability, cybersecurity).
  • Coordinate verification/validation activities and support test execution.
  • Analyze defects and drive root-cause investigation and resolution.
  • Ensure compliance with medical regulations and standards (e.g., ISO 13485, IEC 60601, ISO 14971).
  • Prepare design documentation, technical reports, and support design reviews.
  • Collaborate with R&D, Quality, Manufacturing, and Regulatory teams throughout the product lifecycle.

Qualifications

  • Bachelor’s degree in Electrical, Biomedical, Systems, or related engineering field (Master’s preferred).
  • 3 years of experience as a Systems or Product Engineer, ideally in the medical device or healthcare domain.
  • Experience with systems engineering tools (e.g., DOORS, Jama, Polarion).
  • Strong understanding of requirements management, integration, and validation.
  • Working knowledge of regulatory frameworks (FDA, ISO, IEC).
  • Excellent problem-solving, communication, and collaboration skills.

Job Tags

Full time,

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