LCE Project Manager

Role: LCE Project Manager

Location: Raritan, NJ

Duration: Contract

Job Description:

Required Skills:

• 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 supplier's 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 CR's and CN's
• 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 understanding of 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