Process Development Engineer Ii

As a Process Development Engineer II, you will develop new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working to drive continuous yield improvement. Responsibilities will include but are not limited to: Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for yield improvement projects through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies. Develop fixtures, tooling, and equipment. Develop process specifications which ensure user needs are met. Perform process characterizations and qualifications (IQ/OQ/PQ). Manage required builds for yield improvement projects in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues.  Comply with applicable FDA and international regulatory laws/standards. Perform other duties as assigned or required. Nice to Have 2+ years of experience developing products and/or manufacturing processes in the medical device industry Knowledge of SolidWorks and engineering statistics Some experience or knowledge with Coils/Stents/Braid Manufacturing processes such as laser cutting, laser welding (similar/dissimilar materials), heat setting, electropolishing, braiding, crimping, swaging, cleaning processes, etc. Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design). Knowledge of design and process FMECA, process validation, and process control. Knowledge of design for manufacturability and lean methodologies.