Principal System Engineer

🕒 Abril 12

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Full Spectrum

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1982

🧬 Biotecnologia

🔒 Cibersegurança

🤖 Inteligência Artificial

💰 Private equity em 2021-04

Biotechnology • Cybersecurity • Artificial Intelligence

A <Full Spectrum> é uma consultoria de desenvolvimento de produtos e engenharia especializada em produtos regulados para medtech e ciências da vida. Eles desenvolvem dispositivos médicos em conformidade, sistemas diagnósticos e terapêuticos, instrumentação para ciências da vida, saúde digital/SIS e robótica regulada, e fornecem engenharia de software e sistemas, cibersegurança, integração de IA/ML, verificação e validação, e consultoria em conformidade regulatória para acelerar produtos do conceito ao mercado.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• bonus eligible