System Architect - Medical Devices

Blatchford is an innovative, multi-award-winning, global, manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices. Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users. Through innovation, science, technology, and maintaining a clear focus on people, we make mobility possible. Due to the continued growth and development of our dynamic, multi-disciplinary R&D team, we have an exciting opportunity for a System Architect. This role is offered on a hybrid working pattern, with the expectation of two days per week at our Basingstoke Head Office. The role As System Architect, you will be responsible for the holistic view of the system defining the products, ensuring they meet functional, technical, and business requirements, whilst ensuring they are robust, scalable and safe. You will also be responsible for the definition and maintenance of the platform for future products. Key duties. Developing the overall system architecture, ensuring it aligns with business goals and technical requirements. Gathering and harmonising requirements using MBSE, collaborating with stakeholders and working close with the technical team to ensure proper design implementation and system integration. Ensuring the product design is carried on following relevant standards (i.e. ISO-13485, ISO-14971) and in compliance with company QMS. Actively contributing to the quality improvement process: Leading CAPAs, participating to the Change Management activities, supporting the products roadmap definition and updating relevant QMS procedures. Creating and maintaining high quality technical documentation and contribute to Design Reviews. Effectively communicating status on a regular basis to management and interact with peers to optimise the activities. What are we looking for? To be considered for the System Architect opportunity, you will have the following: Essential skills MSc in Mechanical, Electronic or Software Engineering BSc/BEng, with a proven track record applying System Engineering principles. Solid Systems Engineering design experience, ideally within the medical device industry or other regulated industry. Experience implementing and applying MBSE. Familiarity with SysML. Experience with MDD/MDR. Experience applying ISO-13485 and ISO-14971. Familiarity with requirements and verification management tools such as DOORS or JAMA Drive for continuous improvement A naturally inquisitive problem solver What can we offer you? As System Architect, you will receive the following: Benefits Highly completive salary Flexible, hybrid working. 25 days holiday (rising with service) Option to purchase additional annual leave. Pension Death in service Discounted shopping and leisure activities Health cash plan Cycle to work scheme. Opportunity to be part of an award-winning organisation with a culture that centres around our core values; courage, learning, integrity, collaboration, and innovation