Full Spectrum
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Full Spectrum is a leading provider of product development solutions, including software and system development and testing services. We boast a 40-year history in successfully designing and developing over 1,000 FDA regulated medical devices and information systems, along with non‑regulated solutions. As one of the earliest ISO 13485 certified software providers in the domain, Full Spectrum has a proven track record of helping our customers translate their business objectives into successful commercial products.
Technology has never been more present in our lives than today. Everything from connected medical devices to robotics to mobile apps is becoming more a part of daily life. A career at Full Spectrum will allow you to be at the cutting edge of innovation. If it excites you to have direct involvement with the business side of innovation and technological advancement by engaging with a diverse set of customers, then this is the place for you. We have a passionate team of experienced professionals who have first‑hand experience developing products and solutions that create market value. Our clients depend on us to develop their next innovative product. Come help us build the future!
Responsibilities
Safety Risk Analysis:
Proficient with planning system risk analysis for complex medical devices that contain software, understand and identify potential harms and hazards, perform bottom‑up failure analysis (FMEA), and apply risk through the lifecycle.
Project and V&V Leadership:
Experience with iterative development, key tasks and documentation for medical devices, V&V strategy, planning, and test development including test planning, design, and test case creation.
Requirements Management:
Experience developing and implementing requirement structure schema and hierarchy using management tools, requirement allocation, traceability, and requirement elaboration from user needs to system/software design requirements.
Compliance Engineering:
Familiar with key standards and FDA guidance for devices that contain software (IEC 60601‑1, IEC 62304, ISO 14971, IEC 62366, IEC 60601‑1‑8, 21 CFR 820, GPSV, design control, software submission guidance).
Software Testing Strategy:
Understanding of software lifecycle/IEC 62304, including unit, system, and GUI testing.
Cybersecurity Process and Compliance:
Experience and understanding of typical tasks and documentation needed to support FDA compliance.
Minimum Requirements
Experience working in Systems Engineering applying tasks to address system safety analysis, requirements management, project management, compliance, and cybersecurity processes.
Leadership experience in medical device development, defining activities, identifying project risks, and communicating clearly with team members.
Training and real‑time guidance to engineers in software testing, understanding documentation requirements in a regulated environment.
Familiarity with IEC 13485, ISO 14971, ISPE GAMP‑5, 21 CFR 820, ISO/TIR 80002‑2, AAMI TIR‑32, General Principles of Software Validation, Final Guidance for Industry and FDA Staff (2002), IEC 60601‑1.
Understanding of software risk processes (IEC 62304, TIR‑32, TIR 80001) and design/process risk models (ISO 14971) for test risk control.
Solid background in electrical engineering and familiarity with basic mechanical engineering, medical device design and manufacturing, electrical test (instrumentation and software interactions).
Educational Requirements
Bachelor’s degree in software, electrical, computer engineering, or related science discipline with a minimum of 8 years relevant experience (advanced degree in engineering or science is a plus).
Nice to Have
Minimum four years of software development experience in C/C++, SW design and architecture, machine learning systems, real‑time/embedded programming, object‑oriented programming.
Additional Experience
Good understanding of design controls and regulatory compliance.
Experience with technical documentation in a regulated industry.
Prior work in a regulated environment and medical software development following development standards and processes.
Clear understanding of regulatory requirements with regulatory affairs partners, regulatory strategy, system intent, and launch strategy.
Self‑starter with strong work ethic and initiative.
Familiarity with Agile methodology and version control.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Full Spectrum is a leading provider of product development solutions, including software and system development and testing services. We boast a 40-year history in successfully designing and developing over 1,000 FDA regulated medical devices and information systems, along with non‑regulated solutions. As one of the earliest ISO 13485 certified software providers in the domain, Full Spectrum has a proven track record of helping our customers translate their business objectives into successful commercial products.
Technology has never been more present in our lives than today. Everything from connected medical devices to robotics to mobile apps is becoming more a part of daily life. A career at Full Spectrum will allow you to be at the cutting edge of innovation. If it excites you to have direct involvement with the business side of innovation and technological advancement by engaging with a diverse set of customers, then this is the place for you. We have a passionate team of experienced professionals who have first‑hand experience developing products and solutions that create market value. Our clients depend on us to develop their next innovative product. Come help us build the future!
Responsibilities
Safety Risk Analysis:
Proficient with planning system risk analysis for complex medical devices that contain software, understand and identify potential harms and hazards, perform bottom‑up failure analysis (FMEA), and apply risk through the lifecycle.
Project and V&V Leadership:
Experience with iterative development, key tasks and documentation for medical devices, V&V strategy, planning, and test development including test planning, design, and test case creation.
Requirements Management:
Experience developing and implementing requirement structure schema and hierarchy using management tools, requirement allocation, traceability, and requirement elaboration from user needs to system/software design requirements.
Compliance Engineering:
Familiar with key standards and FDA guidance for devices that contain software (IEC 60601‑1, IEC 62304, ISO 14971, IEC 62366, IEC 60601‑1‑8, 21 CFR 820, GPSV, design control, software submission guidance).
Software Testing Strategy:
Understanding of software lifecycle/IEC 62304, including unit, system, and GUI testing.
Cybersecurity Process and Compliance:
Experience and understanding of typical tasks and documentation needed to support FDA compliance.
Minimum Requirements
Experience working in Systems Engineering applying tasks to address system safety analysis, requirements management, project management, compliance, and cybersecurity processes.
Leadership experience in medical device development, defining activities, identifying project risks, and communicating clearly with team members.
Training and real‑time guidance to engineers in software testing, understanding documentation requirements in a regulated environment.
Familiarity with IEC 13485, ISO 14971, ISPE GAMP‑5, 21 CFR 820, ISO/TIR 80002‑2, AAMI TIR‑32, General Principles of Software Validation, Final Guidance for Industry and FDA Staff (2002), IEC 60601‑1.
Understanding of software risk processes (IEC 62304, TIR‑32, TIR 80001) and design/process risk models (ISO 14971) for test risk control.
Solid background in electrical engineering and familiarity with basic mechanical engineering, medical device design and manufacturing, electrical test (instrumentation and software interactions).
Educational Requirements
Bachelor’s degree in software, electrical, computer engineering, or related science discipline with a minimum of 8 years relevant experience (advanced degree in engineering or science is a plus).
Nice to Have
Minimum four years of software development experience in C/C++, SW design and architecture, machine learning systems, real‑time/embedded programming, object‑oriented programming.
Additional Experience
Good understanding of design controls and regulatory compliance.
Experience with technical documentation in a regulated industry.
Prior work in a regulated environment and medical software development following development standards and processes.
Clear understanding of regulatory requirements with regulatory affairs partners, regulatory strategy, system intent, and launch strategy.
Self‑starter with strong work ethic and initiative.
Familiarity with Agile methodology and version control.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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