Medical Device Manufacturing Engineer — Process & Validation

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

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.