Director of Manufacturing Engineering & External Operations

Real Staffing; Irvine (CA); On-site; USD 180,000 - 250,000; Full time

Job summary

Real Staffing seeks a Director of Manufacturing Engineering to lead manufacturing industrialization, supplier operations, and commercialization readiness for complex Class III interventional medical devices.

This leadership role will drive manufacturing engineering and external operations in a fast-paced, scalable environment, partnering with R&D, Quality, Regulatory, Clinical, and Supply Chain to ensure successful clinical and commercial execution.

Qualifications

• 10+ years of manufacturing engineering, industrialization, technical operations, or manufacturing leadership experience within medical devices.
• Hands-on experience supporting Class III medical devices, catheter-based technologies, or other complex interventional products.
• Strong expertise in FDA Design Controls, PFMEA, process capability, and manufacturing risk management.

Responsibilities

• Lead manufacturing engineering & external operations organization.
• Drive manufacturing industrialization, design transfer, and commercial launch readiness for complex Class III medical devices.
• Partner with R&D teams to implement DFM and Design for Scalability initiatives.
• Oversee contract manufacturers and critical suppliers, ensuring robust manufacturing processes and operational performance.
• Lead process validation activities including IQ, OQ, and PQ protocols.
• Establish manufacturing governance frameworks, KPIs, supplier performance metrics, and operational excellence programs.
• Support regulatory submissions, audits, inspections, CAPA activities, and change management processes.
• Develop long-term manufacturing scale-up strategies aligned with company growth objectives.
• Drive continuous improvement initiatives focused on quality, yield, throughput, capacity, and cost optimization.

Education

Bachelor's degree in Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline

Job description

Real Staffing seeks a Director of Manufacturing Engineering to lead manufacturing industrialization, supplier operations, and commercialization readiness for complex Class III interventional medical devices.

This leadership role will drive manufacturing engineering and external operations in a fast-paced, scalable environment, partnering with R&D, Quality, Regulatory, Clinical, and Supply Chain to ensure successful clinical and commercial execution.