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About Instylla:

Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups.The company's flagship product, Embrace Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.

Position Summary/Role and Responsibilities:

The Vice President of Operations is primarily responsible for production, manufacturing engineering, supply chain, inventory management, and production planning for Instylla's liquid embolic and delivery device portfolio. This role leads and optimizes all operational functions across the organization. The Vice President of Operations partners closely with the CTO and other functional leaders to transform innovative technologies into efficient, scalable, and commercially successful products.

Operational Leadership

• Build scalable operational frameworks that support rapid growth and product commercialization.
• Develop and execute operational strategies aligned with company growth objectives.
• Lead day-to-day operations across manufacturing engineering, production, supply chain, and facilities.
• Establish performance metrics, KPIs, and operational dashboards to monitor efficiency and effectiveness.
• Provide leadership with operational insights and recommendations.
• Develop and manage operational budgets and forecasts.
• Identify opportunities for cost reduction and operational efficiencies.
• Support strategic planning, expansion initiatives, and commercialization efforts.

Manufacturing & Production

• Oversee manufacturing operations to ensure safety, quality, cost efficiency, and timely delivery.
• Drive production planning and capacity management initiatives.
• Implement lean manufacturing principles and continuous improvement programs.
• Optimize workflows, equipment utilization, and production processes.

Supply Chain & Procurement

• Ensure continuity of supply for critical materials, equipment, and components.
• Develop strategic sourcing and supplier management programs.
• Manage inventory strategies to balance availability and working capital objectives.
• Negotiate contracts and build strong relationships with key suppliers and partners.
• Ensure manufacturing and supply chain practices remain compliant with FDA Quality System Regulation and ISO 13485 requirements.

Leadership

• Provide leadership with operational insights and recommendations.
• Recruit and develop high-performing operations teams.
• Monitor staffing levels and build organizational capability.

Supervisory Responsibilities:

• Manufacturing Manager
• Director of Supply Chain & Supplier Management
• Manufacturing Engineering Manager

Qualifications and Education Requirements:

• Bachelor's degree in Engineering, Operations Management, Manufacturing, Supply Chain, Business Administration, or a related field.
• Minimum of 10 years of experience in medical device companies, with specific responsibility for manufacturing, supply chain, or operations leadership and new product introduction.
• Experience in interventional radiology, interventional oncology, or combination product manufacturing is strongly preferred.

Knowledge/Skills:

• Knowledge of medical device manufacturing processes and quality systems, including FDA Quality System Regulation and ISO 13485.
• Knowledge of supply chain, procurement, and inventory management practices.
• Knowledge of scaling manufacturing for commercial and clinical stage medical device products.
• Ability to effectively lead and develop a multidisciplinary team.

Preferred Skills:

• Experience with liquid embolic, hydrogel, or polymer-based device manufacturing.
• Experience taking a PMA-approved device from clinical to full commercial scale.
• Experience establishing manufacturing and supply chain operations at an early commercial-stage medical device company.
• Familiarity with combination products and multi-component delivery kits.

Working Conditions:

• Mobility and some light lifting.
• Some domestic and international travel required.
• Extended periods of time working on a computer and in a manufacturing environment.

Additional Notes:

This position reports directly to the Chief Technology Officer, and has organizational responsibility for Instylla's manufacturing and supply chain functions.