Manufacturing Engineer

Katalyst CRO; Pleasanton (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO, located in Pleasanton, California, is seeking a Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry. The role emphasizes supporting regulated production environments and improving operational efficiency.

The ideal candidate will have hands-on experience with PTC Windchill, manage process validation activities, and ensure compliance with quality and regulatory standards. Strong cross-functional collaboration skills are essential for enhancing production workflows.

Qualifications

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

Responsibilities

• Supported manufacturing engineering activities in a regulated medical device manufacturing environment.
• Managed part creation, BOM development, updates, and configuration control using PTC Windchill.
• Executed and supported IQ/OQ/PQ validation activities for manufacturing processes and equipment.

Skills

Manufacturing operations

Process validation (IQ/OQ/PQ)

PTC Windchill

Statistical analysis (Minitab)

Cross-functional collaboration

Education

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

Tools

Minitab

Manufacturing Execution Systems (MES)

PTC Windchill

Job description

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