Full Spectrum
Overview
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 are 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
Drive Systems Engineering on multiple engineering projects with direct customer interface and project leadership to manage tasks based on client needs. Lead Safety Risk Analysis for complex medical devices (that contain software), identify harms and hazards, perform bottom-up failure analysis (FMEA), and apply risk management across the lifecycle. Provide Project and V&V Leadership with experience in iterative development, V&V strategy and planning, and test development including test planning, design, and test case creation. Manage Requirements: develop and implement requirement structures, allocate requirements, and traceability matrices; elicit requirements from clients and translate user needs into system and software design requirements. Ensure Compliance Engineering familiarity with standards and FDA guidance for software in medical devices (e.g., IEC60601-1, IEC62304, ISO14971, IEC62366, IEC60601-1-8, 21 CFR 820; GPSV and FDA design controls). Develop Software Testing strategy with understanding of IEC62304 and end-to-end testing (unit to GUI). Demonstrate Cybersecurity process and documentation to support FDA compliance. Qualifications
Must Have: Minimum Requirements Experience in Systems Engineering applying tasks for system safety analysis, requirements management, project management concepts, and compliance and cybersecurity processes. Leadership experience in medical device development with responsibility to define activities, identify project risks, and communicate with project teams. Ability to train and guide engineers in Software Test, focusing on documentation requirements in a regulated environment; provide consultation on process changes while minimizing audit exposure. Familiarity with IEC 13485; ISO 14971; ISPE GAMP-5; 21 CFR 820; ISO/TIR 80002-2; AAMI TIR-32; Software Validation principles; FDA industry guidance and regulatory documents; and ongoing awareness of industry trends. Understanding of software risk processes (IEC62304, TIR-32, TIR80001) and risk models (ISO14971) for testing. Solid background in Electrical engineering with basic Mechanical engineering familiarity; exposure to Medical Device design and manufacturing; familiarity with electrical testing (instrumentation and software interaction). Educational Requirements Bachelor’s Degree in Software, Electrical, or Computer Engineering or related science, with a minimum of 8 years of relevant experience (advanced degree a plus). Nice to Have Minimum 4 years of Software development experience with relevant skills, languages, tools, platforms & methodologies. Software Design and Architecture; experience with Machine Learning systems and algorithms. Real-Time & Embedded Programming vs. Application Programming; Object Oriented Programming concepts. Strong understanding of design controls and regulatory compliance; experience with technical documentation in a regulated industry. Regulatory affairs collaboration, regulatory strategy, and launch planning experience. Self-starter with strong work ethic; familiarity with Agile methodology and version control. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing and Software Development
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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 are 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
Drive Systems Engineering on multiple engineering projects with direct customer interface and project leadership to manage tasks based on client needs. Lead Safety Risk Analysis for complex medical devices (that contain software), identify harms and hazards, perform bottom-up failure analysis (FMEA), and apply risk management across the lifecycle. Provide Project and V&V Leadership with experience in iterative development, V&V strategy and planning, and test development including test planning, design, and test case creation. Manage Requirements: develop and implement requirement structures, allocate requirements, and traceability matrices; elicit requirements from clients and translate user needs into system and software design requirements. Ensure Compliance Engineering familiarity with standards and FDA guidance for software in medical devices (e.g., IEC60601-1, IEC62304, ISO14971, IEC62366, IEC60601-1-8, 21 CFR 820; GPSV and FDA design controls). Develop Software Testing strategy with understanding of IEC62304 and end-to-end testing (unit to GUI). Demonstrate Cybersecurity process and documentation to support FDA compliance. Qualifications
Must Have: Minimum Requirements Experience in Systems Engineering applying tasks for system safety analysis, requirements management, project management concepts, and compliance and cybersecurity processes. Leadership experience in medical device development with responsibility to define activities, identify project risks, and communicate with project teams. Ability to train and guide engineers in Software Test, focusing on documentation requirements in a regulated environment; provide consultation on process changes while minimizing audit exposure. Familiarity with IEC 13485; ISO 14971; ISPE GAMP-5; 21 CFR 820; ISO/TIR 80002-2; AAMI TIR-32; Software Validation principles; FDA industry guidance and regulatory documents; and ongoing awareness of industry trends. Understanding of software risk processes (IEC62304, TIR-32, TIR80001) and risk models (ISO14971) for testing. Solid background in Electrical engineering with basic Mechanical engineering familiarity; exposure to Medical Device design and manufacturing; familiarity with electrical testing (instrumentation and software interaction). Educational Requirements Bachelor’s Degree in Software, Electrical, or Computer Engineering or related science, with a minimum of 8 years of relevant experience (advanced degree a plus). Nice to Have Minimum 4 years of Software development experience with relevant skills, languages, tools, platforms & methodologies. Software Design and Architecture; experience with Machine Learning systems and algorithms. Real-Time & Embedded Programming vs. Application Programming; Object Oriented Programming concepts. Strong understanding of design controls and regulatory compliance; experience with technical documentation in a regulated industry. Regulatory affairs collaboration, regulatory strategy, and launch planning experience. Self-starter with strong work ethic; familiarity with Agile methodology and version control. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing and Software Development
#J-18808-Ljbffr