Systems Engineer - Medical Devices jobs in United States
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Global Connect Technologies ยท 22 hours ago

Systems Engineer - Medical Devices

positionMilwaukee, WI
timeFull-time
remoteOnsite
seniorityMid Level
date3+ years exp

Global Connect Technologies is a company focused on medical devices, and they are seeking a Systems Engineer to lead system-level requirements and develop system architecture. The role involves coordinating verification and validation activities, ensuring compliance with medical regulations, and collaborating with various teams throughout the product lifecycle.

Information Technology & Services
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H1B Sponsor Likelynote

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

Qualification

Systems engineering toolsRegulatory frameworksRequirements managementMedical device experienceProblem-solvingCommunicationCollaboration

Required

Bachelor's degree in Electrical, Biomedical, Systems, or related engineering field
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

Preferred

Master's degree in Electrical, Biomedical, Systems, or related engineering field

Company

Global Connect Technologies

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Global Connect Technologies is a fast-growing automotive and IT engineering services company based in the USA.
dateFounded in 2022
location
Michigan , US
people-size2-10 employees

H1B Sponsorship

Global Connect Technologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (4)

Funding

Current Stage
Early Stage
Company data provided by crunchbase