Company Description Inspiration Healthcare is a British based, global provider of medical technology, and our mission is to pioneer medical technology that improves outcomes of patients, starting with the very first breaths of life. We provide high-quality, innovative products to patients around the world that help to improve patient outcomes, and we actively invest in innovative product opportunities, disruptive technologies and, of course, our people. The Group currently consists of three companies: Inspiration Healthcare Ltd, SLE Ltd and Viomedex Ltd and, under these brands, we sell neonatal intensive care and operating theatre equipment around the world through a network of distributors into over 75 countries. We also offer a full range of ambulatory infusion care devices for both hospital and homecare applications to customers across the UK and Ireland. Products range from highly sophisticated capital equipment through to single-use disposables all of which can help improve outcomes of extremely sick patients. We can proudly admit that we haven't come this far without entrepreneurial spirit, a solution driven attitude, and a determination to improve outcomes for premature and sick babies. So if making a positive difference to other people's lives resonates with you and you believe that you have what it takes to flourish and succeed in this role, then we'd love to hear from you. Position Job Purpose (Role Definition): The systems engineer holds the core technical responsibility for Product Creation. They are responsible for the technology that allows successful implementation of projects that meet business needs, including time, cost, quality, and productivity. The systems engineer will, as part of the R&D group: Contribute strongly to setting and achieving technology roadmaps, processes and tools for the business, Take overall technical responsibility for the appropriate project architecture, project feasibility studies and project development road map for a given product, Maintain good high-level awareness and provide assessments of architecture, technology, tools, applications, and general vendor and industry trends. Main Duties and Responsibilities Identify and understand customer needs. Specify system requirements. Evaluate alternative architectures and technologies. Select specific architectures and technologies. Development and management of system requirements, including user workshops. Elaboration of system requirements into system architecture and design. Create documentation to a level suitable for handoff to downstream engineering. Execution of engineering governance activities such as Critical Design reviews (CDR). Support Verification and Validation activities, including defect triage. System qualification, acceptance, and release at product and system levels. Attend project meetings to review new ideas and design proposals, to communicate relevant project risks to the Group, and to drive for continuous improvement of the tools and processes. Share technical expertise, knowledge, and experience with peer groups in project teams and functional areas. Maintain awareness of regulatory changes to ensure proposed designs meet relevant safety, regulatory and performance requirements. Evaluate gap analysis of IHC products against the up revision of relevant medical standards. Conducting risk management activities. Reduce timescale, product and resource risks using detailed design FMEAs and preliminary hazard analysis, and incremental Lean techniques. Management Responsibilities None Requirements Experience and Qualifications Required Mandatory Bachelor's degree (or equivalent) in relevant engineering or scientific discipline. Excellent analytical and problem-solving skills. Experience of translating process standards on risk management and PEMS development into workable methodologies. Experience of translating product specific standards on basic safety and essential performance into product design solutions. Strong track record of design and development of complex, real-time systems in a strongly commercial environment. Demonstrable experts in their specific domain (Software, Mechanics, Electronics, or Physics) with good appreciation of one or more of the other disciplines. Experience in System Engineering disciplines: Requirements Management, Architecture Definition, System Design, Qualification, Assurance, and Release. Strong Requirements and Risk analysis skills. ISO 14971. Systems Engineering techniques & tools, including MBSE, SysML, UML. Understanding of the end-to-end System Engineering lifecycle (e.g., ISO/IEC/IEEE 15288). Flexibility to work across diverse projects in a collaborative team environment. Desirable Experience in a cross-functional development environment. Experience of R&D in a regulated environment (preferably medical ISO 13485, IEC 60601). Knowledge of real-time control system theory and practice Good commercial and business awareness. Working knowledge of lean new product development tools. Good communicator and team player with a passion for technology. Experience of designing to general standards for PCLCs and for security of networked medical systems would be an advantage. Other information As well as being dedicated to providing a great place to work in a rewarding, stimulating and environmentally conscientious environment, we offer an extensive range of benefits, listed below, and actively support learning and development opportunities for all: 25 days' holiday pa, rising to 28, plus bank holidays Compressed 4 day week & blended working options Enhanced pension scheme (with salary sacrifice option) Bonus schemes Sharesave scheme Mind & body wellbeing support Healthcare cash plan Retailer discounts Life assurance Enhanced and equal leave & pay for new parents Cycle to Work SmartTech scheme Electric Car Benefit Employee referral scheme Travel season ticket loan