Job Description
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,