Director of Manufacturing

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.