Senior Medical Device Manufacturing Engineer - Process Lead

Katalyst CRO; San Diego (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Senior Manufacturing Engineer in San Diego to own technical manufacturing processes, validations, equipment readiness, and capacity expansion. You will drive process development, validation, and optimization to ensure product quality and regulatory compliance, supporting commercialization and continuous improvement across internal and external teams.

Responsibilities include leading root cause investigations, coordinating with suppliers, and advancing automation

Qualifications

• Bachelor's degree in engineering or related field with relevant experience.
• Requires strong knowledge of manufacturing process validation and equipment qualification.
• Experience with statistical analysis and process control methodologies.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for semi automation equipment installation, processing, and material handling.
• Adapts machine or equipment design to factory and production conditions, incorporating inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify efficiency and initiates corrective actions for quality.
• Develops and maintains manufacturing process specifications, work instructions, and engineering documentation.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation.
• Supports automation initiatives and advanced manufacturing technologies.
• Serve as the primary technical escalation point for complex manufacturing and quality issues.
• Lead root cause investigations utilizing structured problem-solving tools such as 5 Why, Fishbone Analysis, and Statistical Analysis.
• Lead initiatives to improve yield, reduce scrap, increase throughput, and optimize labor utilization.
• Partner with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
• Develop manufacturing strategies for commercial production ramp-up, identify and eliminate bottlenecks impacting manufacturing performance.
• Ensures processes and procedures follow FDA Quality System Regulations, ISO 13485 requirements, and company procedures.

Skills

Process design

Problem solving

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

SAP

MES

AutoCAD

SolidWorks

Minitab

Job description

Katalyst CRO is seeking a Senior Manufacturing Engineer in San Diego to own technical manufacturing processes, validations, equipment readiness, and capacity expansion. You will drive process development, validation, and optimization to ensure product quality and regulatory compliance, supporting commercialization and continuous improvement across internal and external teams.

Responsibilities include leading root cause investigations, coordinating with suppliers, and advancing automation