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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