Lead Process Development Engineer, Medical Devices

Katalyst CRO; Covington (GA); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking a Staff Process Development Engineer to lead manufacturing process development for NPD, product design changes, and technology transfer in a regulated medical device setting. You will partner with R&D, Product Development, Manufacturing Engineering, Quality, and Operations to ensure manufacturability, scalability, and operational excellence.

Responsibilities include leading DFMA reviews, ATR analyses, DOE studies, and capabililty assessments while driving process

Qualifications

• Bachelor's or higher in engineering with 8+–10+ years in process development/manufacturing engineering for medical devices or regulated industries.
• Experience supporting New Product Development and product commercialization.

Responsibilities

• Lead process development and industrialization activities for new product introductions, enhancements, and manufacturing transfers.
• Collaborate with R&D and Product Development during concept, feasibility, design verification, and design transfer phases.
• Perform comprehensive DFMA assessments to optimize architecture, assembly methods, cost, quality, and throughput.
• Conduct CAD-based ATR analyses and tolerance stack-up evaluations to validate assembly robustness.
• Develop manufacturing process strategies, tooling concepts, fixtures, and automation.

Skills

DFMA

ATR analyses

DOE

SPC

pFMEA

CAD/SolidWorks

Lean Six Sigma

Cross-functional collaboration

NPD support

Regulatory experience

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

SolidWorks

Job description

Katalyst CRO is seeking a Staff Process Development Engineer to lead manufacturing process development for NPD, product design changes, and technology transfer in a regulated medical device setting. You will partner with R&D, Product Development, Manufacturing Engineering, Quality, and Operations to ensure manufacturability, scalability, and operational excellence.

Responsibilities include leading DFMA reviews, ATR analyses, DOE studies, and capabililty assessments while driving process