Senior Systems Engineer - Medical Devices

Senior Systems Engineer

Pay: 120k-$150k base + full benefits + tons of perks

Location: North Chicago (off Webster/Cortland and the 90/94 fwy)

Position Overview

The Senior Systems Engineer will be responsible for leading the design and development of complex medical device systems. This role involves collaborating with cross-functional teams to ensure compliance with FDA regulations and ISO requirements while delivering innovative solutions that meet customer needs.

Key Responsibilities

• Lead the design and development of medical device subsystems
• Ensure compliance with FDA regulations and ISO requirements
• Collaborate with hardware and software teams to integrate system components
• Conduct system-level analysis and risk assessments
• Develop and maintain system design documentation
• Participate in design reviews and provide technical guidance to junior engineers

Qualifications

• Bachelor's degree in Engineering or related field; Master's degree preferred
• 5+ years of experience in systems engineering, preferably in the medical device industry
• Strong understanding of FDA regulations and ISO 13485 requirements
• Experience with system design and subsystem integration
• Proficiency in requirements management and design tools
• Excellent problem-solving skills and attention to detail
• Any AI/ML experience would be a bonus

Benefits

• Strong Career Growth
• We are an award winning medical device company in the AI/ML space
• Medical insurance
• Vision insurance
• Dental insurance
• Disability insurance
• Generous/Open PTO policy