
51 - 200 employees
Founded 1982
🏥 Healthcare
💼 Consulting
🏭 Manufacturing
💰 Private equity on 2021-04
Healthcare • Consulting • Manufacturing
<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.
🕒 April 12
🇺🇸 United States – Remote
💵 $150k - $205k / year
⏰ Full Time
🔴 Lead
⚙️ Systems Engineer
👻 Ghost score 41%
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51 - 200 employees
Founded 1982
🏥 Healthcare
💼 Consulting
🏭 Manufacturing
💰 Private equity on 2021-04
Healthcare • Consulting • Manufacturing
<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.
• 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.
• 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.
• bonus eligible
Apply Now🕒 April 8
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