Medical Device Engineer - Risk Management

The Medical Device Engineer acts as a technical author and documentation specialist for device risk management activities. The role supports design, development, industrialisation and lifecycle management programmes by creating and maintaining inspection-ready documentation that aligns with design controls, regulatory expectations and risk management requirements. The position ensures technical consistency and traceability across key development deliverables while partnering with Quality, Regulatory, Safety and Device Subject Matter Experts. Key Responsibilities: Risk Management Technical WritingAuthor, update and maintain risk management documentation for autoinjector and safety syringe programmes.Develop and manage risk management plans, risk analyses, risk evaluation records, traceability documentation and risk management reports.Ensure alignment between hazards, harms, risk controls, verification evidence and residual risk assessments.Support Benefit-Risk Board activities through preparation of risk management content and summaries.Conduct gap assessments against technical documentation and regulatory submissions. Documentation Quality, Traceability & Data IntegrityPerform detailed consistency, completeness and traceability reviews across risk management files and design control documentation.Verify technical accuracy and alignment across design inputs, testing evidence, usability outputs and post-market information where relevant.Identify documentation gaps, ambiguities and inconsistencies that could impact audits, submissions, design reviews or risk conclusions. Cross-Functional Project SupportCollaborate with Device Programme Leads, Human Factors specialists, Quality, Regulatory and Safety teams.Gather, challenge and consolidate technical input from stakeholders.Facilitate risk documentation review meetings and track actions through to completion.Provide regular updates regarding documentation status, open issues and programme readiness. Continuous ImprovementSupport development and maintenance of templates, guidance documents and documentation standards.Drive harmonisation of risk documentation practices across device programmes.Contribute to digitisation and process improvement initiatives related to risk management and technical documentation.Promote clear, consistent and inspection-ready technical writing practices. Essential Qualifications & ExperienceBachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Technical Writing or a related discipline.8-15 years of experience within medical devices, drug-device combination products, pharmaceuticals, technical writing or regulated documentation environments.Demonstrated experience authoring or maintaining risk management files, design control documentation, FMEAs, usability documentation or verification-related documentation.Mandatory experience in autoinjector development.Strong knowledge of ISO 14971 risk management principles.Good understanding of design controls, technical documentation and regulated product development environments.Knowledge of medical device and combination product regulatory frameworks including:EU MDR, Article 117, GSPR, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, GMP requirements. Skills & CompetenciesExcellent technical writing, editing and document structuring capabilities.Strong attention to detail with a focus on consistency, completeness and traceability.Ability to manage multiple documentation deliverables and review cycles simultaneously.Effective stakeholder management and communication skills.Ability to challenge unclear requirements and drive cross-functional alignment.Collaborative and proactive approach to problem solving.Experience using document management systems, Microsoft Word and Microsoft Excel.Strong interest in patient-centric drug delivery technologies and autoinjector products.