Process Development Engineer

Katalyst CRO; City of Rochester (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a 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 with R&D, Product Development, Manufacturing Engineering, Quality, and Operations to ensure products are designed for manufacturability, assembly, scalability, and operational excellence.

Qualifications

• Bachelor's Degree with 10+ years of experience in Process Development, Manufacturing Engineering, Product Development, or Advanced Manufacturing within Medical Device or regulated industries.
• 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.
• Knowledge of DFSS, DOE, 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.

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 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 KPIVs and KPOVs to ensure process capability, product quality, and manufacturing consistency.
• Design, execute, and analyze process characterization studies, DOE, capability assessments, and process validation activities.
• Lead pFMEA activities and implement risk mitigation plans throughout product lifecycle development.
• Develop manufacturing standards, DFMA review processes, and stage-gate product development support.
• Evaluate and improve existing manufacturing and assembly processes through Lean, Six Sigma, and continuous improvement methodologies.
• Support equipment selection, process qualification, process validation, and vertical start-up activities for new lines.
• Establish process controls, monitoring strategies, and statistical methods for long-term performance.
• Review and modify CAD models and drawings to ensure manufacturing, assembly, tolerance, and quality compliance.

Skills

DFMA methodologies

DOE

Statistical methods (SPC)

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Tools

CAD

SolidWorks

Job description

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.

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.