Job Purpose (Role Definition)
The Principal 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. They 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;
* lead and mentor engineers, while remaining hands-on with risk & requirements management, comprehension of standards and architecture.
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
Line management responsibilities of the Systems Team, including hiring of new team members.
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 & Electronics preferred; Mechanics 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.
* Experience of R&D in a regulated environment (preferably medical ISO 13485, IEC 60601).
* Knowledge of real-time control system theory and practice
Desirable:
* Good commercial & business awareness.
* Working knowledge of lean new product development tools.
* Experience of designing to general standards for PCLCs and for security of networked medical systems would be an advantage.
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