SoCode are proud to represent a global leader in the healthcare industry, who have recently promoted two Principle Scientists in the Device and Product Performance team, leaving a gap for two additional Principal Scientists! This is a great opportunity for an expert looking to make a significant impact in the development of Combination Products.The ideal candidate will have:A Degree in Science/Engineering (Master’s preferred)7+ years of experience in drug delivery and/or medical device development3-5 years of Combination Product PerformanceWorking knowledge of design control requirements (FDA 21 CFR part 820 and ISO 13485)Strong background in the development and validation of analytical methodsExpertise in statistical techniques for data analysisExperience with regulatory submissions and complianceExperience being an SME, presenting to technical and non-technical stakeholders.Knowledge in device functionality testing and material assessmentsExpertise in developing test methods and device characterisationWhat will you be doing?Provide subject matter expertise to support the development of Combination ProductsLead a team to plan and execute design verification and reliability strategiesManage technical interface between drug product and device teams during combination product developmentDevelop design requirements and specifications based on regulatory, user needs, and comparator product characterisationCreate test methods to assess device functionality and product performance, including evaluating and implementing new lab testing equipmentPerform material assessments, biological evaluations, and extractables profiling for device componentsProvide technical support during manufacturing and assembly process developmentUse statistical techniques to inform design decisions and validate test methodsEnsure all activities adhere to GDD Quality Management system standardsInterested in the role? Then you can either:Submit your CV by applying to this job advert.Connect with us on LinkedIn for an informal discussion.Call our office for more information – Google SoCode and ask for more details.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering, Design, and Project ManagementIndustriesMedical Equipment Manufacturing
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