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.

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