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): We are seeking a highly skilled and detail-oriented Risk Management Engineer (Medical Devices) to join our team. The primary responsibility of this role is to implement the risk management process for our medical device products. The successful candidate will be responsible for identifying and assessing potential risks associated with our devices, developing risk mitigation strategies, and ensuring compliance with applicable regulations and standards. Main Duties and Responsibilities Implement risk management processes for medical device products throughout their lifecycle, in compliance with applicable regulations and standards (e.g., ISO 14971). Evaluation and continuous improvement of Risk Management processes. Lead risk assessments to identify potential hazards and associated risks, considering all phases of the product lifecycle. Collaborate with cross-functional teams, including R&D, Usability, Cybersecurity, Quality Assurance, Regulatory Affairs, and Clinical Affairs, as well as gather necessary information and input for risk assessments. Develop risk mitigation strategies and plans, including risk control measures and risk acceptance criteria. Evaluate the effectiveness of risk mitigation measures and revise as necessary. Monitor and analyse post-market data, including complaints and adverse events, to identify potential risks and assess the need for further risk mitigation. Collaborate with the Design Control team to integrate risk management activities into the product development process. Ensure risk management documentation is accurate, up to date, and maintained according to regulatory requirements. Stay up to date with regulatory changes, industry best practices, and emerging trends related to medical device risk management, as well as identify training needs and appropriate ways to satisfy these to ensure knowledge is kept up to date. Management Responsibilities None Requirements Experience and Qualifications Required Mandatory Bachelor's degree in a relevant scientific or engineering field. Minimum 3 to 5 years of experience in medical device risk management. Strong knowledge of risk management principles and methodologies, including ISO 14971. Familiarity with relevant regulations and standards, such as FDA regulations and European Medical Device Regulation (MDR). Experience in conducting risk assessments and developing risk management plans. Knowledge of statistical analysis and tools used in risk management. Experience with post-market surveillance and complaint handling processes is a plus. Desirable Experience in class I and II medical devices Knowledge of EN62366 Microsoft TFS Experience with manufacturing risks Knowledge of Clinical Evaluation Knowledge of the Neonatal Intensive Care environment MDCG 2019-16 (Cybersecurity) Key Skills and Competencies Passionate about medical devices and risk management within a multidisciplinary team The ability to work successfully alone and in a cross-functional team; Hands-on self-starter with excellent attention to detail High standard of report writing skills and the ability to interpret technical documentation An enthusiasm for and an interest in neonatal and adult critical care, and a determination to embrace and support at all times our core values of Research Driven, Outcome Changing, Pioneering, and Patient Focused; Knowledgeable of quality assurance principles and policies; Clinical interest and ability to interpret clinical information; A flexible attitude and the determination to see projects through to their conclusion; An enquiring and analytical mind with exceptional attention to detail; Excellent interpersonal, communication (written and oral) and presentation skills; 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