2h ago

Principal System Engineer

Remote

$150,000-$205,000 / year

F
full-timelead Remotemedical device

🛠 Tech Stack

💼 About This Role

You'll lead systems engineering for medical device projects, translating clinical needs into compliant engineering realities. Your core impact is driving safety, risk management, and V&V strategies to ensure life-saving technology reaches patients. You'll work across diverse client projects, offering variety and technical growth.

🎯 What You'll Do

  • Lead project execution aligning client needs with team deliverables.
  • Perform safety risk analysis and FMEA for complex medical devices.
  • Drive cybersecurity threat modeling and FDA compliance processes.
  • Define V&V strategies and oversee system integration testing.

📋 Requirements

  • Bachelor's degree in Software, Electrical, Biomedical, or Computer Engineering.
  • 8+ years of relevant Systems Engineering experience.
  • Proven leadership in medical device development and stakeholder communication.
  • Deep knowledge of design controls, IEC 62304, ISO 14971, and risk management.

✨ Nice to Have

  • Scripting in Python or C/C++ and OOP.
  • Experience with Machine Learning systems and real-time/embedded programming.
  • Familiarity with Agile and CI/CD pipelines.

🎁 Benefits & Perks

  • 💰 Bonus eligible role.
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