Manufacturing Engineer

Katalyst CRO; Pleasanton (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Engineer with 3–4 years of experience in medical device manufacturing to support regulated production environments. You will manage part creation, BOMs, configuration control with PTC Windchill, and govern MES documentation to ensure traceability and compliance.

You will collaborate with manufacturing, quality, and R&D teams to improve production efficiency, lead validation activities (IQ/OQ/PQ) and develop PFMEA to mitigate process risks, enabling robust

Qualifications

• 3–4 years of experience in medical device manufacturing.
• Experience with Windchill and MES documentation and configuration control.
• IQ/OQ/PQ validation experience in a regulated environment.
• PFMEA development and maintenance for risk mitigation.
• Statistical analysis using Minitab for process improvement.

Responsibilities

• Support manufacturing engineering activities in a regulated medical device environment.
• Manage part creation, BOM development, updates, and configuration control using Windchill.
• Maintain MES documentation and manufacturing procedures to ensure traceability.
• Participate in process development and data-driven improvement initiatives.
• Execute IQ/OQ/PQ validation activities for processes and equipment.
• Develop PFMEA to identify and mitigate process risks.
• Collaborate with manufacturing, quality, and R&D to ensure smooth workflows.
• Drive continuous improvement to enhance quality, yield, and efficiency.

Skills

PTC Windchill

MES systems

IQ/OQ/PQ validation

PFMEA

Minitab

Process improvement

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Mechanical/Industrial/Biomedical Engineering

Tools

PTC Windchill

MES

Job description

• Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments.


• Experienced in manufacturing operations, process validation (IQ/OQ/PQ), configuration management, and continuous process improvement.


• Skilled in managing product data and documentation through PTC Windchill and MES systems while ensuring compliance with quality and regulatory standards.


• Strong background in cross-functional collaboration with manufacturing and quality teams to improve production efficiency and maintain robust documentation control.


• Supported manufacturing engineering activities in a regulated medical device manufacturing environment


• Managed part creation, BOM development, updates, and configuration control using PTC Windchill


• Maintained and updated MES documentation and manufacturing procedures to ensure compliance and traceability


• Participated in process development and process characterization activities to improve manufacturing efficiency


• Executed and supported IQ/OQ/PQ validation activities for manufacturing processes and equipment


• Developed and maintained PFMEA (Process Failure Mode and Effects Analysis) to identify and mitigate process risks


• Performed statistical analysis using Minitab to support process improvement and data-driven decision-making


• Collaborated with cross-functional teams including manufacturing, quality, and R&D to ensure smooth production workflows


• Supported continuous improvement initiatives to enhance product quality, yield, and operational efficiency


• Ensured adherence to regulatory requirements and internal quality management systems

Job Summary

• Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments.


• Experienced in manufacturing operations, process validation (IQ/OQ/PQ), configuration management, and continuous process improvement.


• Skilled in managing product data and documentation through PTC Windchill and MES systems while ensuring compliance with quality and regulatory standards.


• Strong background in cross-functional collaboration with manufacturing and quality teams to improve production efficiency and maintain robust documentation control.

Roles & Responsibilities

• Supported manufacturing engineering activities in a regulated medical device manufacturing environment


• Managed part creation, BOM development, updates, and configuration control using PTC Windchill


• Maintained and updated MES documentation and manufacturing procedures to ensure compliance and traceability


• Participated in process development and process characterization activities to improve manufacturing efficiency


• Executed and supported IQ/OQ/PQ validation activities for manufacturing processes and equipment


• Developed and maintained PFMEA (Process Failure Mode and Effects Analysis) to identify and mitigate process risks


• Performed statistical analysis using Minitab to support process improvement and data-driven decision-making


• Collaborated with cross-functional teams including manufacturing, quality, and R&D to ensure smooth production workflows


• Supported continuous improvement initiatives to enhance product quality, yield, and operational efficiency


• Ensured adherence to regulatory requirements and internal quality management systems

Experience

• 3-4 years of experience in medical device manufacturing or highly regulated manufacturing environments


• Hands-on experience with PTC Windchill for PLM and configuration management


• Experience working with MES (Manufacturing Execution Systems) and manufacturing documentation control


• Exposure to process validation activities including IQ/OQ/PQ


• Experience in PFMEA development and maintenance for risk analysis


• Working knowledge of statistical tools such as Minitab for process analysis and improvement


• Strong communication, teamwork, and cross-functional collaboration skills in regulated environments

Education

• Bachelor's degree in Mechanical, Industrial, Biomedical Engineering, or related field