Manufacturing Engineer

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

Job Summary

We are seeking an experienced Manufacturing Engineer with a strong background in the Medical Device industry to support manufacturing process development, validation, optimization, and continuous improvement initiatives. The ideal candidate will have hands‑on experience developing and optimizing manufacturing processes, executing IQ/OQ/PQ process validations, troubleshooting production and equipment issues, and supporting quality and regulatory requirements.

Roles & 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.

Job Summary

We are seeking an experienced Manufacturing Engineer with a strong background in the Medical Device industry to support manufacturing process development, validation, optimization, and continuous improvement initiatives. The ideal candidate will have hands‑on experience developing and optimizing manufacturing processes, executing IQ/OQ/PQ process validations, troubleshooting production and equipment issues, and supporting quality and regulatory requirements.

Roles & 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.

Education & Experience

• 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.