Medical Device Manufacturing Engineer — Process Validation

Katalyst CRO; Plano (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Manufacturing Engineer with a strong Medical Device background to support process development, validation, optimization, and continuous improvement initiatives. The role involves hands-on experience with IQ/OQ/PQ validations, troubleshooting production issues, and ensuring quality and regulatory compliance.

You will develop and optimize processes, tooling, and equipment, apply DFM principles, and collaborate with Design Engineering and R&D to ensure

Qualifications

• Bachelor's degree in mechanical engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• Advanced degree or additional technical certifications in manufacturing, quality, or engineering is a plus.
• 34+ years of experience in Manufacturing Engineering, preferably within the Medical Device industry.
• Hands-on experience with manufacturing process development, characterization, optimization, and implementation.

Responsibilities

• Develop, characterize, optimize, and implement manufacturing processes and technologies for medical device production.
• Plan and execute process validation activities, including IQ, OQ, and PQ.
• Develop and maintain process validation protocols, reports, and supporting documentation.
• Perform PFMEA/FMEA activities to identify and mitigate manufacturing process risks.
• Apply Lean Manufacturing and Continuous Improvement methodologies to improve process efficiency, quality, productivity, and cost.
• Analyze manufacturing data and process performance using Minitab and other statistical/data-analysis tools.
• Conduct Root Cause Analysis (RCA) and implement effective corrective and preventive actions.
• Support production troubleshooting and resolve manufacturing process and equipment-related issues.
• Develop and optimize manufacturing processes, tooling, fixtures, and equipment.
• Apply Design for Manufacturability (DFM) principles when evaluating new products, processes, tooling, and design alternatives.
• Collaborate with Design Engineering and R&D teams to ensure products are manufacturable and production ready.
• Support equipment qualification, installation, and implementation activities.
• Identify opportunities to improve process capability, yield, throughput, reliability, and overall manufacturing performance.
• Prepare and maintain engineering documentation, work instructions, process specifications, and validation records.
• Work closely with Quality Engineering to ensure compliance with applicable quality and regulatory requirements.
• Support investigations, nonconformances, CAPA activities, and process improvement initiatives as required.
• Ensure manufacturing processes comply with applicable FDA regulations, ISO 13485, GMP, and company quality-system requirements.
• Provide technical support to production teams and assist with implementation of process improvements.
• Communicate effectively with cross‑functional teams and manage multiple engineering projects and priorities.

Skills

Lean Manufacturing

Continuous Improvement

Root Cause Analysis

CAPA

Data Analysis

Cross-functional Communication

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Advanced degree or certifications in manufacturing, quality, or engineering

Tools

Minitab

Job description

Katalyst CRO is seeking an experienced Manufacturing Engineer with a strong Medical Device background to support process development, validation, optimization, and continuous improvement initiatives. The role involves hands-on experience with IQ/OQ/PQ validations, troubleshooting production issues, and ensuring quality and regulatory compliance.

You will develop and optimize processes, tooling, and equipment, apply DFM principles, and collaborate with Design Engineering and R&D to ensure