23 Dec
Project Manager #2442
Massachusetts, Cambridge , 02142 Cambridge USA

job summary:Project Lead - Device Design and DevelopmentClient is seeking a qualified candidate for the role of project lead - device design and development in the Medical Devices & Packaging Department.The position will lead the execution of medical devices and packaging projects, ranging from various route of administration like SC, IM, IV, Intrathecal and supporting patient-centric, safe, reliable and innovative devices, digital devices and packaging technology projects, aligned to the drug pipeline, as well as execute, communicate deliverables, plans with internal stakeholders and external partners for client.The position will lead cross functional teams to drive key activities throughout development phases of device and combination products, and facilitate the deliverables to support regulatory filing, product launch and post market surveillance. location: Cambridge, Massachusettsjob type: Contractwork hours: 8am to 4pmeducation: Bachelors responsibilities:Responsibilities:Will lead client's cross functional Combination & PMA Device Development efforts specific to prefilled syringes, auto-injectors, pens, on-body injectors, transdermal, delivery to CNS and packaging solutions.The ideal candidate will be an experienced project lead that can effectively and efficiently bring optimized products to market by leveraging external partnerships in collaboration with internal Technical Design, Human Factors, Packaging, Manufacturing Science, Engineering, Quality and Regulatory Affairs etc.The candidate is considered a device subject matter expert (SME), and will provide project and engineering leadership in device/packaging and/or system identification, feasibility, development, qualification, launch readiness and commercialization for delivery systems and packaging.Area of focus will be on leading a development team and where needed providing guidance regarding identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, human factors, risk assessments, DHF creation, general project team support, and extensive collaboration with both internal stakeholders and external development partners.Utilizes effective and efficient project management tools and best practices to deliver project goalsIdentifies applications of functional knowledge and existing methodologies to lead teams to solve complex problems; provides advice on a wide range of issues within area of subject matter expertiseLiaise with third parties such as specialist manufacturers, design consultants and contractors qualifications:

  • Experience level: Experienced
  • Minimum 10 years of experience
  • Education: Bachelors
  • Project Manager
  • Medical Device
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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