Principal Process Engineer

Principal Process Engineer

Requirements

• Bachelor’s Degree and 7+ years of Process Development/Optimization experience OR advanced degree with 5+ years of experience

Responsibilities

• Drive the process evaluations, solution and project development, implementation, and continuous improvement of manufacturing processes with a strong emphasis on Statistical Process Control (SPC) and process optimization
• Develop project scopes, schedules, budgets, and implementation plans while ensuring compliance with safety, quality, and regulatory standards
• Analyze workflows, problem-solve on complex manufacturing issues, and lead site and operations innovation cross-functional teams to implement data-driven solutions that enhance product quality, improve efficiency, and reduce scrap and rework
• Collaborate with site manufacturing leadership, quality, engineering, finance, and operations excellence teams to achieve strategic business objectives and foster a culture of continuous improvement
• Lead cross-functional projects from concept through production release, including equipment installation, process validation, and process monitoring and control
• Communicate findings and proposals to upper management
• Coach and teach Statistical Process Control development and implementation on existing processes
• Track metrics to discover areas for improvement and identify areas for improvement
• Work with manufacturing, finance, and operations excellence to estimate production costs and project savings
• Develop SPC implementation project charter, status updates, and changes
• Provide thorough instructions for successful implementation of process changes
• Review production data and design specifications working in partnership with manufacturing and quality to understand critical process parameters
• Design procedures for designing control charts and action plans that affect process capability and product performance
• Lead or provide critical review of root cause investigations and support corrective action solutions, planning and execution to ensure product quality
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques
• Ensure processes and procedures are in compliance with regulations, applicable safety and quality standards
• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products
• Integrate equipment and material capabilities to meet process module target specifications and technology target specifications
• Review product development requirements for compatibility with processing methods to determine costs and schedules
• Lead the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations

Preferred Qualifications

• Experience leading and managing large projects
• Excellent technical, organizational, and analytical skills
• Ability to persuade others to change existing practices
• Knowledge of what a process transfer function is
• Knowledge of Statistical Process Control (SPC) principles
• Experience troubleshooting manufacturing issues and identifying root cause
• Demonstrated ability to coach others on SPC and how to improve manufacturing processes through the application
• Experience with SPC development and implementation specifically for manufacturing equipment
• Experience on improvement efforts, site coaching for teams on common standards, planning methods and improvement approach
• Medical device experience
• Data transformation skills, e.g. Python and R
• Ability to create predictive models and simulate process performance through Monte Carlo methods
• Six Sigma, or equivalent, Green Belt Certified
• Have experience with processes such as automated systems, and automated, semi-automated & manually operated manufacturing equipment