Systems Engineering and Product Ownership • Take a whole-product view of development, from initial feasibility and concept selection through detailed design, integration and verification. • Turn stakeholder needs into practical requirements and trace them through to verification • Manage Technical Risk and develop effective Risk Control Measures to ensure products are safe to use and meet regulatory constraints • Comfortable managing mechanical, electronics, firmware, software and other specialists together so that individual subsystems work as one coherent product. • Spot technical gaps and risks early, agree priorities with the team and drive engineering issues through to resolution. Requirements, Architecture and Interfaces • Take the lead on defining, reviewing and maintaining system requirements, making sure they are clear, testable and linked to the needs they address. • Shape system architecture, data flow, and long-term technical roadmaps across multiple teams. • Develop functional architectures, break products into manageable subsystems and agree technical responsibilities across engineering disciplines. • Define interfaces between hardware, embedded software, controls and mechanical systems, including signals, power, communications and physical connections. • Establish and assess key performance budgets, such as power, timing, accuracy or throughput, using analysis and test data to guide decisions. Technical Problem Solving and Risk • Take a hands-on approach to technical challenges, working with engineers to investigate unexpected behavior and find the root cause of problems. • Plan and carry out focused feasibility work, experiments and prototype tests to answer important engineering questions early. • Manage design reviews and risk assessments, helping the team make sound decisions on performance, reliability, safety and design maturity. • Manage DFMEA and Risk Registers, assessing risk acceptability and tracing risks through Risk Control Measures to implementation Integration, Test and Verification • Plan how subsystems will be brought together and tested, with clear methods and acceptance criteria for demonstrating product performance. • Support the build and integration of electromechanical prototypes, helping diagnose issues across electronics, controls, firmware, software and mechanisms. • Prepare test methods and plans, participate in testing, interpret results and follow through on failures and design changes. • Maintain clear evidence that the product meets its requirements through traceability documentation, and support design handover and transfer with the necessary technical information. Working with Clients and Project Teams • Act as a technical lead point of contact, giving project teams a clear view of the overall design and the implications of technical decisions. • Explain technical options, trade-offs and recommendations clearly to clients and colleagues, using the right level of detail for the audience. • Work with project managers and technical leads to plan engineering activities, estimate effort and manage technical dependencies and priorities. • Collaborate with suppliers and external partners to agree specifications, resolve interface issues and integrate their work into the product. • Support writing proposals, costing and planning work, technical workshops and design reviews, and help colleagues use systems engineering methods in a practical, proportionate way. Requirements • Track record of at least 10 years' experience designing products in a highly regulated industry, preferably medical devices. • Hands-on and practical engineering skills, willing and able to get stuck in to designing solutions and able to demonstrate a passion for engineering in and out of work. • Able to see the complete product while still understanding enough technical detail to make informed engineering decisions at all levels and engineering disciplines. • Strong problem-solving skills, with the curiosity and judgement to challenge assumptions and work through unfamiliar technical problems. • Pragmatic and organized, able to bring structure to an ambiguous brief without creating unnecessary complexity or paperwork. • Confident working across disciplines, with technical strengths in mechanical and electrical engineering or mechatronics. • A clear communicator who can build strong relationships with clients, explain technical issues and influence decisions constructively. • Able to balance performance, usability, cost, risk and development timescales when recommending engineering solutions. • Proactive, collaborative and accountable, with the drive to take ownership and see technical issues through to completion. • Bachelor's or Master’s degree in electrical engineering, mechanical/mechatronics, systems engineering or a closely related engineering discipline, or equivalent practical experience. • Experience developing physical products that combine electronics, software or firmware, and mechanical components, ideally through more than one stage of development. • Practical experience defining system requirements, developing architectures and managing interfaces between engineering disciplines. • Hands-on experience building, integrating, testing or troubleshooting electromechanical systems and resolving issues that span hardware and software. • A good grounding in sensors, actuators, embedded controls, power and communications, and confidence interpreting schematics and technical test results. • Experience planning and carrying out system-level tests, assessing performance against requirements and documenting engineering findings. • Familiarity with requirements tools, simulation, modelling, scripting or model-based systems engineering (including SysML) would be beneficial. • Strong AI skills and experience in applying tools to streamline technical activities, including requirements management • Experience in a product development consultancy, medical devices, diagnostics, scie