Manufacturing Engineer - Medical Device Process Excellence

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

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