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LCE Project Manager

Location: Cincinnati
Posted on: March 19, 2023

Job Description:

Job Description:

Pay Range $45.00 - $50.00


  • Experience in Life Cycle Engineering with project management.
  • Experience in a medical device industry or other regulated environment.
  • Experience with electromechanical design, component manufacture, general engineering, and system testing.
  • Experience in project management and execution of small and mid-scale projects ($50k-$500K budgets).
  • Demonstrable experience with external suppliers of plastics, metal, and electrical components.
  • Demonstrable experience with manufacturing and assembly of medical devices or similar commercial products.
  • Ability to manage the suppliers offshore resources.
  • Lead Design and Development activities relating to life cycle engineering projects of Medical Devices.
  • Lead Design Control and documentation across the life cycle of the product.
  • Lead Design Change activities to Mitigate Product Complaints.
  • Execute CAD Drawing and Modeling as per the Project Scope.
  • Act as subject matter expert for all CRs and CNs.
  • Experience in writing IQ / OQ / PQ, Test Method Validation protocols and reports.
  • Lead Design verification testing including Developing Test matrix, conducting the required engineering tests and report generation.
  • Draft and review documentation/Protocol related to procedures,special instruction & reports etc.
  • Experience in leading self-directed work teams.
  • Ability to understand surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system / regulatory environment.
  • Project Management certification (e.g., FPX or PMP) preferred.
  • Ability to work in ambiguity, prioritize and lead work, and demonstrate ability to independently judge, define, and manage risk in development of manufacturing solutions for our endo- mechanical platform.
  • Work one-on-one with customer stakeholders to identify procedure and/or product opportunities and evaluate potential technical solutions.
  • Provide innovative product, system & component design solutions.
  • Understanding of cGMP, Good Documentation Practices, and Regulations.

Keywords: CYNET SYSTEMS, Cincinnati , LCE Project Manager, Executive , Cincinnati, Ohio

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