Manufacturing Eng Lead – External Ops (Medical Devices)

Real; Irvine (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Real is seeking a Director of Manufacturing Engineering to lead manufacturing industrialization, external operations, and commercialization readiness for complex Class III interventional medical devices in Irvine, CA. You will partner with R&D, Quality, Regulatory, Clinical, and Supply Chain while managing contract manufacturers to ensure successful clinical and commercial launches.

This leadership role demands deep regulatory knowledge and a proven track record in scaling manufacturing networks

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• 10+ years of manufacturing engineering/industrialization/leadership experience in medical devices.
• Hands-on experience with Class III medical devices and interventional products.
• Experience managing outsourced manufacturing and supplier relationships.
• Strong knowledge of IQ/OQ/PQ, PFMEA, process capability, and risk management.
• Knowledge of FDA Design Controls, ISO 13485, ISO 14971, and EU MDR.

Responsibilities

• Lead and develop the Manufacturing Engineering & External Operations organization.
• Drive manufacturing industrialization, design transfer, and commercial launch readiness for Class III devices.
• Partner with R&D to implement DFM and scale-up initiatives.
• Oversee contract manufacturers and suppliers to ensure robust processes.
• Lead process validation activities including IQ, OQ, PQ protocols.
• Establish governance, KPIs, supplier performance metrics, and operational excellence programs.
• Support regulatory submissions, audits, CAPA, and change management.
• Develop long-term scaling strategies aligned with company growth.
• Drive continuous improvement for quality, yield, throughput, capacity, and cost.

Education

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

Job description

Real is seeking a Director of Manufacturing Engineering to lead manufacturing industrialization, external operations, and commercialization readiness for complex Class III interventional medical devices in Irvine, CA. You will partner with R&D, Quality, Regulatory, Clinical, and Supply Chain while managing contract manufacturers to ensure successful clinical and commercial launches.

This leadership role demands deep regulatory knowledge and a proven track record in scaling manufacturing networks