Director of Manufacturing

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

A venture-backed medical device innovator developing next-generation cardiovascular technologies is seeking a Director of Manufacturing Engineering to lead manufacturing industrialization, supplier operations, and commercialization readiness for complex Class III interventional medical devices.

This is a high-impact leadership opportunity for an experienced manufacturing and operations professional who thrives in fast-paced environments and enjoys building scalable systems, leading external manufacturing networks, and driving products from development through commercial launch.

The Opportunity

As the leader of Manufacturing Engineering & External Operations, you will be responsible for establishing and scaling manufacturing capabilities within a virtual manufacturing environment. You will work cross-functionally with R&D, Quality, Regulatory, Clinical, and Supply Chain teams while partnering closely with contract manufacturers and critical suppliers to ensure successful clinical and commercial execution.

Key Responsibilities

• Lead and develop the 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 Design for Manufacturability (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.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• 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.
• Proven success managing outsourced manufacturing environments, supplier relationships, and product commercialization programs.
• Strong expertise in process validation (IQ/OQ/PQ), PFMEA, process capability, and manufacturing risk management.
• Deep understanding of FDA Design Controls, FDA QSR/QMSR, ISO 13485, ISO 14971, and EU MDR requirements.
• Experience leading cross-functional initiatives in highly regulated environments.
• Ability to travel domestically and internationally up to approximately 30%.

Why This Role?

• Join a rapidly growing medical device organization developing transformative cardiovascular technologies.
• Play a critical role in shaping manufacturing strategy and commercialization efforts.
• Work directly with executive leadership and global stakeholders.
• Influence supplier strategy, manufacturing scale-up, and operational excellence initiatives.
• Be part of an innovative, collaborative, and mission-driven team focused on improving patient outcomes worldwide.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.