Medical Device Engineer

Job Description

Job Title: Engineering - Medical Device EngineerLocation: REMOTE - Once or twice a fortnight in CambridgeDuration: 12 MonthsRate: 25 - 30 per hour PAYE SummaryCapable mechanical or product development engineer needed for project technical lead in the medical sector. Working as part of a friendly and motivated team leading the development of drug delivery devices, the role may include tasks from all stages of devicedevelopment from user requirement capture and due diligence assessment of vendor activities through to validation, transfer-to-manufacture and complaints investigations. The role requires a combination of technical and planning skills to predict (and mitigate)product risks. You will need to demonstrate an ability to understand the patient and the device whilst balancing project and business requirements. The role is based in the Device Centre of Excellence (DCoE) near Cambridge, UK and may require occasional travel.Role FunctionsSupport the design and development of drug delivery devicesProduce models and drawings using 3D CADModify and develop 3D CAD & drawings from non-native CAD systemsProduce and approve requirement specifications for external suppliers (UK and abroad)Analyse supplier designs to identify areas critical to function, likely failure modes and design sensitivities.Identify, analyse and communicate user needsPerform tolerance analysis using RSS or Montecarlo methodologyDesign test rigs and challenge partsPerform Engineering testing (laboratory-based) to evaluate design proposals and establish functional performance characteristicsAnalyse test results to determine design performance and acceptabilityRisk management assessment and mitigation, including DFMEA and input to UFMEA.Support supplier design reviews and Pfizer internal design reviewsBalance technical requirements with user preference dataSupport Design for Manufacture and Design for Assembly discussions with internal and external design teamsCreate documentation to support medical device development and industrializationInteract effectively with suppliers and other Pfizer groupsCapabilities and KnowledgeEssentialCAD (preferably Pro-Engineer / Creo) and associated document management systemsEngineering calculations eg friction, beam bendingExperience of using risk assessment tools including FMEAExperience of design with plastic componentsManagement and prioritisation of project tasksWriting clear reports, documents and presentationsUnderstanding of quality management systemsGood understanding of complex mechanical systemsExcellent communication skills with other disciplinesCritical thinking, problem solving and trouble-shootingDesirableKnowledge of ISO13485Experience of user-centred designExperience of electro-mechanical systemsManagement of others tasks, including managing suppliersKnowledge of injection moulding.Experience of FEAKnowledge of SolidworksEducation and ExperienceDegree in Mechanical Engineering or equivalentExperience within the medical device industry would be a benefitPersonPractical, analytical, pro-active, pragmaticFocussed on the userCapable of both working in a team and leading own independent work through to a conclusionCollaborativeCommunicates well with internal and external team members. Articulates ideas and concepts clearly to all levels and technical abilitiesAble to learn and understand new concepts quicklyCapable of seeing the wider implications of technical decisions