Vice President of Operations

Instylla•Bedford, MA

13d•$200,000 - $260,000•Onsite

About The Position

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.

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.
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.

Nice To Haves

Experience in interventional radiology, interventional oncology, or combination product manufacturing is strongly preferred.
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.

Responsibilities

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.
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.
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.
Recruit and develop high-performing operations teams.
Monitor staffing levels and build organizational capability.