Process Improvement Engineer

Job Responsibilities:

• Support continuous improvement projects, root cause analysis, and capital improvements
• Responsible for engineering-related support of manufacturing equipment and processes including continuous improvement, scrap reduction, and capacity improvements or optimization
• Lead project teams to increase productivity, reduce scrap, implement lean manufacturing, and improve system availability, safety, and product quality
• The ability to recognize opportunities and appropriately prioritize projects based on potential improvement and risk is imperative
• Perform root cause investigations for CAPA processes
• Report findings to cross-functional team, propose and implement corrective actions, and verify corrective action effectiveness
• Develop SOPs for equipment operation, part inspection, equipment changeover, and preventive maintenance activities that are current and accurate
• Work with vendors to provide quotes and identify system specifications
• Coordinate project timelines to meet manufacturing requirements
• Write, Review, and Execute PVP, IQ, OQ, PQ, FMEA, and RA documents and summaries
• Familiarity with cGMPs, ISO, and other Medical Device Industry regulations and specifications
• Support manufacturing by diagnosing system or process failures and working with Maintenance and/or the Tool Room personnel to implement system fixes

Qualifications:

• Bachelor's degree or equivalent in Biomedical, Mechanical, or Manufacturing Engineering
• 3+ years' of industry experience
• Experience with IQ/OQ/PQ, FMEA, and RA is preferred