LCE Project Manager
Company: CYNET SYSTEMS
Posted on: March 19, 2023
Pay Range $45.00 - $50.00
- Experience in Life Cycle Engineering with project
- Experience in a medical device industry or other regulated
- 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
- Lead Design Change activities to Mitigate Product
- Execute CAD Drawing and Modeling as per the Project
- 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
- 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)
- 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
- Work one-on-one with customer stakeholders to identify
procedure and/or product opportunities and evaluate potential
- Provide innovative product, system & component design
- Understanding of cGMP, Good Documentation Practices, and
Keywords: CYNET SYSTEMS, Cincinnati , LCE Project Manager, Executive , Cincinnati, Ohio
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