This role involves leading the regulatory strategy for a cardiology medical device company, focusing on FDA, CE, and UKCA submissions, and ensuring compliance with international regulations. You will work closely with the senior team and regulatory bodies, driving the company's expansion into new markets.
Lead cross-functional teams through the full medical device product lifecycle, from concept to commercialisation, in a multidisciplinary Cambridge environment. The role involves managing timelines and budgets, navigating regulatory pathways, and mentoring junior staff while engaging hands-on with design teams.
Design and develop complex medical devices as part of a multidisciplinary team of mechanical engineers, physicists and electronics engineers. The role is hands-on, spanning CAD, prototyping and functional mechanism design across multiple medical specialisms, including some surgical robotics, with variety rather than a single-device focus.
Develops high-quality C and C++ software across the full development lifecycle, from concept and design through testing and release, for an engineering consultancy building medical devices. Works in a multidisciplinary team alongside software, electronics and mechanical engineers, writing well-tested code and technical documentation. Embedded systems, RTOS, Linux, Qt and IEC 62304 experience are advantageous.
Own data management across a portfolio of clinical studies, from setup through database lock and final data transfer, acting as the primary client contact for data quality and delivery. Configure and test data transfers, write production code, produce ETL-based reports, and maintain GCP documentation, with scope to improve SOPs and explore AI tools.
Develops FPGA and embedded firmware for high-performance data acquisition and signal processing systems used in biomedical research products. Writes VHDL for FPGA functionality and C for low-level hardware control, integrating and debugging digital electronics across the full product lifecycle alongside hardware and software engineers.
Lead information security, product cybersecurity and cyber risk management for a digital health organisation, owning the ISMS, policies and controls. Day to day involves risk assessments, threat modelling, penetration testing oversight, cloud and application security, incident response and supporting audits and regulatory submissions. Works closely with software development, quality, regulatory and clinical teams, acting as the security subject matter expert.
Hands-on regulatory role supporting UKCA and CE marked diagnostics products while progressing new IVD tests. Maintains technical documentation, regulatory strategies, risk management, performance evaluation and post-market surveillance, working closely with Scientific, Data, R&D and Quality teams in a small cross-functional organisation.
Undertake routine and specialist microbiological and molecular investigations across bacteriology, containment level 3, serology, chlamydia and molecular diagnostics, interpreting and reporting results. Operate and maintain automated analysers, manage consumables and use laboratory IT systems while supporting quality management, audits and SOP development. Based at Addenbrooke's Hospital within UKHSA's public health microbiology team.
Lead high-value medical device development programmes from concept through to transfer to manufacture, with a focus on drug delivery systems such as injectables, infusion pumps, microcatheters and active implants. The role combines hands-on mechanical and systems engineering oversight with strategic and commercial direction, mentoring colleagues and identifying business opportunities. Requires international travel to meet clients, investors and manufacturing partners.
Hands-on testing of medical and drug delivery devices, from injectable and inhalation products to robotics and surgical instruments. Covers mechanical and functional testing, environmental stress conditioning, bespoke test rigs and documentation to SOPs, within a multi-disciplinary project team and under supervision.
Develop embedded C and C++ software for medical devices spanning lab and hospital equipment, drug delivery systems and personal sensors. Work across all project stages from concept through design, implementation and manufacture, with substantial client interaction. Target systems include bare metal, RTOS and Linux, with Python used for automated testing.
Mechanical engineer consultant bridging client ambition and technical delivery for drug delivery devices and combination products. Involves concept creation, analysis, modelling, detailed design, rapid prototyping and hands-on experimental work from lab to pilot scale, plus scoping, proposals and client relationship building.
Leads complex medical-device and drug-delivery development programmes from concept through to manufacture, shaping technical strategy amid significant uncertainty. Manages multidisciplinary teams, guides clients through regulatory and commercial decisions, and mentors colleagues while building new business. Based at TTP's Melbourn campus near Cambridge.
Provides statistical expertise across R&D, Clinical, Product Support and Marketing, designing and analysing studies and supporting product algorithms and evidence generation. Sits in a three-person Statistical & Data Services Team, acting as statistical representative on assigned projects and communicating findings to technical and non-technical audiences.
