About the role

What you’ll do

• Lead systems engineering and V&V across the product lifecycle
• Ensure integrated medical systems meet functional, performance, safety, and regulatory requirements
• Verify systems with hardware, firmware, and cloud/desktop software components
• Debug issues in the lab using scopes and write Python test scripts
• Gather feedback and requirements from clinicians in clinical environments
• Support 510(k) submissions or pre-sub meetings

What you’ll need

• Bachelor's or Master's degree in Mechanical, Electrical, Biomedical, Computer, or Software Engineering or related field
• 5+ years of systems engineering experience for medical devices
• 5+ years of hands-on V&V experience for medical devices
• Experience verifying systems with hardware, firmware, and cloud or desktop software components
• Ability to write clear, structured documentation meeting FDA and ISO standards, with a hands-on lab mindset and Python scripting
• Familiarity with clinical environments, cybersecurity testing, wireless medical devices, mobile health apps, EEG/EMG signals, or 510(k) submissions

Original job description