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