Process Development Engineer

Katalyst CRO is seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities within a regulated medical device manufacturing environment. This role involves collaborating with various teams to ensure products are designed for manufacturability and operational excellence.

Responsibilities:

• Lead process development and industrialization activities for new product introductions (NPI), product enhancements, and manufacturing transfers
• Collaborate with R&D and Product Development teams during concept, feasibility, design verification, and design transfer phases to ensure manufacturable product designs
• Perform comprehensive DFMA (Design for Manufacturing & Assembly) assessments to optimize product architecture, assembly methods, cost, quality, and throughput
• Conduct CAD-based Assembly Tolerance Requirement (ATR) analyses and tolerance stack-up evaluations to validate assembly robustness and product performance requirements
• Develop manufacturing process strategies, assembly methodologies, tooling concepts, fixtures, and automation solutions to support scalable production
• Define and establish Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs) to ensure process capability, product quality, and manufacturing consistency
• Design, execute, and analyze process characterization studies, DOE (Design of Experiments), capability assessments, and process validation activities
• Lead Process Failure Mode and Effects Analysis (pFMEA) activities and implement effective risk mitigation plans throughout product lifecycle development
• Develop manufacturing standards, best practices, and structured DFMA review processes to support stage-gate product development activities
• Evaluate and improve existing manufacturing and assembly processes through Lean Manufacturing, Six Sigma, and continuous improvement methodologies
• Support equipment selection, process qualification, process validation, and vertical start-up activities for new manufacturing lines
• Establish process controls, monitoring strategies, and statistical methods to maintain long-term manufacturing performance
• Review and modify detailed CAD models and engineering drawings to ensure compliance with manufacturing, assembly, tolerance, and quality requirements

Requirements:

• Bachelor's Degree with 10+ years of experience, or Master's Degree with 8+ years of experience in Process Development, Manufacturing Engineering, Product Development, or Advanced Manufacturing within Medical Device or other highly regulated industries
• Extensive experience supporting New Product Development (NPD) and product commercialization activities
• Strong expertise in Design for Manufacturing and Assembly (DFMA) methodologies
• Hands-on experience performing Assembly Tolerance Analysis (ATR) and tolerance stack-up assessments
• Advanced proficiency with CAD and SolidWorks for product and assembly development
• Experience developing manufacturing processes, assembly systems, fixtures, tooling, and automation solutions
• Strong knowledge of DFSS, DOE, Statistical Process Control (SPC), Process Capability Analysis, and Process Validation methodologies
• Experience leading pFMEA, risk assessments, and process optimization initiatives
• Demonstrated ability to work cross-functionally with R&D, Quality, Operations, Supply Chain, and Manufacturing teams
• Experience within FDA-regulated, ISO 13485, or similarly regulated manufacturing environments preferred
• Medical device manufacturing experience
• Automated assembly and high-volume manufacturing experience
• Lean Manufacturing and Six Sigma certification
• Technology transfer and global manufacturing support experience
• Strong technical leadership, mentoring, and project management skills