The Resonetics NPI (New Product Introduction) Engineer is a key member of the team ensuring Resonetics ' ability to document cutting edge medical device product manufacturing processes for transfer from development to large scale manufacturing. They work in unison as a core team member with the Product Development and Quality Engineering functions to ensure a successful and timely transition from development to commercial production while meeting established goals (i.e., safety, quality, delivery, cost, and productivity). The NPI Engineer optimizes systems for component and assembly manufacturing based on planned demand, location, and quality requirements. As programs progress into commercial manufacturing, the NPI Engineer acts as a technical liaison and key member of the transfer team to facilitate efficient training of production resources. As an experienced resource, the NPI Engineer is expected to help resolve technical and business challenges using data driven decisions.
Release new products and processes using customer or internal specifications. Document manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety. Generate and modify manufacturing process documentation and assure that manufacturing processes and related documentation follow established policies and procedures per Resonetics' established Quality Management System. Utilize LEAN, Six Sigma, DMAIC and other process improvement tools and principles as appropriate for continuous improvement. Document risk management activities (PFMEA/Risk Assessment). Drive utilization of process improvement techniques to make scale-appropriate equipment and process recommendations. Create process documentation and execute training where applicable (Manufacturing Process, Equipment Setup, Preventive Maintenance etc.) as well as associated risk management activities (PFMEA/Risk Assessment). BS or higher in relevant Engineering discipline or equivalent experience. Minimum of 2 years' experience in a manufacturing environment working in an engineering role. Strong communication skills, comfortable with leading and providing project status updates at the team, customer, and leaderships levels. Demonstrated work ethic and understanding of deadline management. Proficient in SolidWorks (or equivalent) for tooling/fixture design. Versed in GD&T and generation of technical drawings. Familiarity with risk management activities (PFMEA/Risk Assessment). Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols. Effective interpersonal skills and adeptness interacting with multiple departments in a culturally diverse employee population. Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.
