Process Development Engineer

Job Description: We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, 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. Required Qualifications: 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. Preferred Qualifications: 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.