System Engineer III - Medical Devices
6 - 10 years
United States
Contract
Remote
2 months ago
About the role
Job Title: System Engineer III
Duration: 12 Month Contract, possible extension/conversion
Location: Milwaukee, WI
Mode: Remote
Responsibilities
• Lead system design and development activities for medical device products
• Translate customer and market needs into technical product requirements
• Own and maintain Design History File (DHF), system specifications, and traceability documentation
• Lead risk management, verification & validation (V&V), and usability activities
• Support system integration, troubleshooting, and issue resolution
• Collaborate with Engineering, Manufacturing, Quality, Regulatory, Marketing, and Service teams
• Ensure compliance with IEC 14971, IEC 62366, and quality management standards
• Provide technical leadership throughout the product lifecycle
Required Skills
• Bachelor’s degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field
• 3+ years of systems engineering or medical device development experience
Strong experience with:
• Requirements management
• Risk management
• Verification & Validation (V&V)
• System integration
• Product lifecycle development
• Knowledge of IEC 14971 and IEC 62366 standards
• Experience with tools/methodologies such as QFD, CTQ, DFR/DFX, and Pugh Matrix
• Strong problem-solving, communication, and leadership skills
• Agile product development experience preferred
• Medical device industry experience preferred, especially diagnostic cardiology systems
Duration: 12 Month Contract, possible extension/conversion
Location: Milwaukee, WI
Mode: Remote
Responsibilities
• Lead system design and development activities for medical device products
• Translate customer and market needs into technical product requirements
• Own and maintain Design History File (DHF), system specifications, and traceability documentation
• Lead risk management, verification & validation (V&V), and usability activities
• Support system integration, troubleshooting, and issue resolution
• Collaborate with Engineering, Manufacturing, Quality, Regulatory, Marketing, and Service teams
• Ensure compliance with IEC 14971, IEC 62366, and quality management standards
• Provide technical leadership throughout the product lifecycle
Required Skills
• Bachelor’s degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field
• 3+ years of systems engineering or medical device development experience
Strong experience with:
• Requirements management
• Risk management
• Verification & Validation (V&V)
• System integration
• Product lifecycle development
• Knowledge of IEC 14971 and IEC 62366 standards
• Experience with tools/methodologies such as QFD, CTQ, DFR/DFX, and Pugh Matrix
• Strong problem-solving, communication, and leadership skills
• Agile product development experience preferred
• Medical device industry experience preferred, especially diagnostic cardiology systems
Skills
Medical Equipment ManufacturingOther