Project Engineer

The Project Engineering position will be responsible for all aspects of product sustainability for the Ligation portfolio from design control related design changes to investigations and root cause analysis and working with the supplier on any design related changes or improvements. This engineer will serve in a technical role with key responsibilities of project management inclusive of collaboration and leadership with key internal and external stakeholders. A successful candidate will understand and be knowledgeable in key aspects of project management, design control, supply chain, manufacturing and inspection requirements as these relate to Product Sustainability. • As an integral part of the project team and or leader of a project team, provides design, manufacturing, supply, component, timing and assembly expertise to projects • Work closely with SME’s to define sample/product acquisition required for aging, packaging, ship test, sterilization, customer labs, samples etc. • Managing project related operations-related communications, upward and downward through the organization; escalating key issues and presenting options for resolution to the Senior Leadership Team. • Responsible for managing / communicating validation schedules including IQ/OQ/PQ, product production within agreed upon scope, budget, timeline and quality with external partners. • Interface with suppliers and manufacturing when implementing new processes. • Ensure all supporting documentation is drafted, approved and documented with SAP and Agile. • Support and lead efforts to generate, review and approve design control documentation. • Develop test plans, protocols, and reports. Analyze and present results, applying engineering analysis as necessary. • Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems. • Drives quality improvements by risk assessment/mitigation eliminating sources of defects in the design, new product introduction and manufacturing processes.