Principal System Engineer

🕒 April 12

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Full Spectrum

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1982

🧬 Biotechnology

🔒 Cybersecurity

🤖 Artificial Intelligence

💰 Private equity on 2021-04

Biotechnology • Cybersecurity • Artificial Intelligence

<Full Spectrum> is a product development and engineering consultancy specializing in regulated medtech and life-sciences products. They develop compliant medical devices, diagnostic and therapeutic systems, life sciences instrumentation, digital health/HIS and regulated robotics, and provide software and systems engineering, cybersecurity, AI/ML integration, verification & validation, and regulatory compliance consulting to fast-track products from concept to market.

📋 Description

• Serve as the primary technical interface for clients, driving Software Systems Engineering for mission-critical medical device projects. • Manage project execution by aligning client needs with team tasks and deliverables. • Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways. • Provide real-time guidance, training, and problem-solving for engineers in Software Test and documentation realms. • Lead planning for complex software-driven medical devices and perform risk assessments in collaboration with clinical teams. • Drive the process for threat model analysis, cyber risk assessments, and incident reporting to ensure FDA compliance. • Develop and implement requirement schemas and hierarchies ensuring allocation and traceability.

🎯 Requirements

• Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline). • Minimum of 8 years of relevant experience in Systems Engineering. • Proven track record in medical device development, identifying project risks, and communicating clearly with stakeholders. • Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration. • Technical Proficiencies: Scripting in Python or C/C++, code inspection, and Object-Oriented Programming. • Emerging Tech: Experience with Machine Learning systems, algorithm management, and real-time/embedded programming. • Modern Methodology: Familiarity with Agile, version control, and automating compliant CI/CD pipelines.

🏖️ Benefits

• bonus eligible