Sr Process Engineer

Job Description:

PRIMARY RESPONSIBILITIES:·Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions 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 equipment and process characterizations and qualifications (IQ/OQ/PQ).
· Manage required builds for new product development in a pilot or 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 re...