Requirements

• BS in Engineering - advanced degree preferred.
• 8-10 years of process engineering experience is required - 12+ years of process engineering is preferred.
• Experience within an FDA-regulated industry is preferred.
• Solid background in Root Cause issues and the ability to solve those issues for high-volume manufacturing.
• Demonstrated experience in new product process design and development for new products/processes with multiple factors, responses and interactions is required in this role.
• Candidates who possess demonstrated experience in new product process design and development and implementation of these processes into manufacturing operations for current products are preferred..
• Experience in a high volume, high speed, and high precision manufacturing environment - extremely tight tolerances/variances - is necessary.
• Demonstrated ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities is required.
• Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of experiments, capability analysis, sampling statistics and techniques, CTQ flow down, C/E Matrix, pFMEA, fish bone diagrams, etc. is required for this role
• Black Belt or Master Black Belt strongly preferred

This is for an industry leader who defines the term "Blue Chip" organization. This company puts a high value on quality of life, skill & career growth and has an opportunity for vertical career tracks along with tremendous benefit and retirement programs.

Responsibilities

• Applying and developing advanced analytics and SPC for the identification of critical process parameters as well as developing monitoring and Real Time control strategies.
• Insures robust identification of, and control strategies for, critical process variables.
• Provide innovative thinking along with a disciplined approach for the rapid, compliant, and high-quality development and manufacture of products across multiple plant locations while ensuring business and regulatory requirements are achieved.
• Provides leadership on process capability and acts as a mentor to more-junior staff.
• Collaborate closely with business partners in R&D, Quality, FOD, MAKE, and Regulatory teams in problem solving and experimental strategy to define and manage process capability improvement efforts on Legacy and new products.
• Assist leadership in identifying improvement projects and ensuring project initiatives align with business objectives.
• Develops implementation cost models for project development and implementation. This position serves as a Technical Expert for key technologies, and writes, reviews and critiques
• Conduct, review and critique data analysis and recommendations from testing and development protocols.
• Relocation assistance available
• keywords: process engineer, PSM, Process safety, project engineer, chemical engineer, six sigma, HAZOP, hazard assessment