Project Manager

Project Manager Youngsville, NC Full-Time, Permanent General SummaryThe Development Project Manager is responsible for leading cross-functional project teams in the transfer of new products into manufacturing. This position: 1) serves as project leader and primary point of contact for assigned development projects and Customers that are medium to large in scope; 2) requires technical expertise in creating & maintaining project plans, tracking project performance and budget, developing & maintaining project & engineering reports, & communicating routinely on all aspects of projects to all stakeholders; 3) assists the Engineering team with the development of cost-effective, robust, & efficient processes, assembly tools & methods; and 4) leads cross functional teams in the transfer of products to our manufacturing environment on time.Primary Duties and ResponsibilitiesCustomer Relationship & Project Team Leadership & Oversight for projects of medium to large scope with a high level of independence (Customer Focus Team Leader)Project File Setup & MaintenanceProject Scope & Cost OversightControl & Reporting with a high level of independenceCross Functional Team Leadership - Internal & External Resource Coordination for Engineering Projects with a high level of independence (Including Scheduling & Tracking of ENG Builds)MVP Initiation & Management thru V&V PhaseNew Vendor Selection, Relationship Development, & Supply Chain Development SupportMaterial Specifications, Bills of Material, Assembly & Packaging Instructions InitiationProduct DFMA Assistance & Support (Including Sterile Pkg & Shipping Configuration Design)Risk Analysis Support[Assembly] Process Development SupportTest Method Development SupportCADDrafting & ToolingFixturing SupportMFG Line Design & Setup SupportValidation Protocol Development & Report Writing SupportXFER to MFG Support - Finalizing Validation Docs, Line Setup & TrainingDepartment Procedure Development & Maintenance SupportProvides leadership and mentoring to junior Project Management and Development staffAssistance in Ensuring ComplianceAdherence to Internal, Contract, FDA, & ISO RequirementsAssistance in Quoting New Business OpportunitiesRequired Qualifications4-year degree in a Scientific or Engineering field (Biomedical, Mechanical, Industrial or Electrical) with at least 8 years of experience in the fieldStrong project management skillsDemonstrated ability to lead & manage a teamExcellent interpersonal skills & written communicationStrong analytical skills & attention to detailHighly motivated self-starter with ability to drive for resultsDemonstrated ability to effectively organize, prioritize & accomplish multiple tasks; makes decisions & solves problems independentlyBackground in medical device development & manufacturingExperience working with medical device compliance to FDA & international standardsExperience in a fast-paced environment where "˜speed to market" is identified as a key performance indicatorStrong computer skills (MS Word, Excel, PowerPoint, Outlook, Project Management Tools, CAD, Statistical Software, Graphic Design Tools)Preferred QualificationsExperience in an ISO 9001 or ISO 13485 manufacturing environmentMedical Device or Pharmaceutical development or manufacturing experienceExperience with device sterile packaging & terminal sterilization processes such as EtO, Gamma, etc.Technical skills in manufacturing processes and methods including flow, layout, assembly and production equipmentCross-discipline engineering experienceExperience in developing & maintaining pFMEAsExperience in troubleshooting and repairing equipmentExperience with heat sealing, vacuum forming, RF welding, high speed packaging lines, adhesive dispensing systems, cuttingpunchingskivingforming thermoplastics, inspection and test equipment (leak testing, scales, force gauges, etc.)Lean Six Sigma Green Belt CertificationExperience with MiniTab, SolidWorks, and electro-mechanical devices & equipment (design, fabricationassembly, installation, qualification, operation)

Created: 2025-02-21