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Development Manager

GxPeople Global · London Area, United Kingdom

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Development Manager – Medical Device DevelopmentLondon (Office-based) | Full-time, Permanent | Competitive salary, DOE + Equity + BenefitsAbout the OpportunityA venture-backed UK medical device company is developing a next-generation diagnostic platform addressing a significant unmet clinical need. Having completed a first-in-human study and with regulatory submission on the horizon, the business is scaling its team ahead of clearance and commercial launch.They're looking for an experienced, hands-on Development Manager to take technical and delivery ownership of their core device development programme — a high-visibility, engineering-led role sitting at the centre of engineering, clinical, regulatory, and supply chain work-streams.Key ResponsibilitiesTake technical ownership of the development programme, owning the Integrated Development Plan (IDP) across hardware, software, and system-level workstreamsLead structured problem-solving on technical blockers — root-cause investigation, design trade-off analysis, and testing strategyChair technical and design reviews, and maintain clear status reporting to leadershipOwn the Design History File (DHF) —content and timeline — aligned to the regulatory submission scheduleLead design transfer into manufacture: process validation, manufacturing documentation, and resolution of design-for-manufacture and yield issues with a contract manufacturerAct as the central coordination point across engineering, clinical affairs, regulatory, quality, and supply chainManage third-party development partners and contract suppliersOwn the development programme budget and cost forecastingPerson SpecificationEssentialDegree in engineering, life sciences, or a related technical discipline5+ years in medical device development, the majority in a hands-on engineering, R&D, or development management capacity not a purely programme/PMO roleDemonstrable track record taking Class II/III devices through development, design transfer, and regulatory submission, including at least one product transferred into validated productionDirect, evidenced experience of design transfer: process validation, manufacturing documentation, and resolution of design-for-manufacture and yield issuesStrong understanding of ISO 13485, design controls, and FDA 510(k) or CE-mark submission processesStrong technical problem-solving instincts, comfortable driving a failure investigation to root causeSound planning discipline (MS Project, Smartsheet, Jira, or equivalent)Clear, confident communicator, able to translate technical complexity for non-technical stakeholdersSelf-starter, comfortable in a lean, fast-moving startup environmentDesirableExperience with complex diagnostic/therapeutic devicesExperience managing US FDA regulatory interactions or GLP/GMP study programmesPrior experience in a Series A–B medical device companyWhat's on OfferA pivotal, high-impact role in a well-funded, commercially focused medical device companyCompetitive salary, equity participation, and benefitsOffice-based in the UK with periodic international travelThe opportunity to help shape both the product and the organisation as it scalesHow to ApplyThis search is being conducted by Feroze Malik at GxPeople Global. To apply, submit a CV and a brief covering note outlining your relevant experience.