Systems Engineer ( Medical Devices)

Intellectt INC5 months ago
Milwaukee, WI, United States
Hybrid
Full-time
Junior Level (1-3 years)

Job Description

Role Highlights

  • End-to-end product development ownership from requirements gathering to product launch
  • System architecture, requirements management, verification & validation
  • Risk management, usability, cybersecurity, and DHF ownership
  • Strong exposure to IEC 62366, IEC 14971, and regulated product environments
  • Collaboration with cross-functional teams including Engineering, QA, Regulatory, Manufacturing, and Marketing
  • Agile product development environment

Preferred Background

  • 3–5 years of Systems Engineering experience
  • Experience with medical devices / diagnostic cardiology products is highly preferred
  • Hands-on experience with QFD, Pugh Matrix, CTQ, DFR, DFX
  • Bachelor’s degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field

Required Skills

DHF Ownership
DFR
IEC 62366
Systems Engineering
QFD
Product Development
Pugh Matrix
Cross-functional Collaboration
IEC 14971
DFX
Agile Methodologies
Cybersecurity
Requirements Management
Risk Management
CTQ
Usability Engineering
Verification & Validation
System Architecture