Systems Engineer - Medical Devices

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.