Manufacturing Engineering Manager

Job Description

Job Description

Salary : $110,000-$175,000

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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 companys flagship product, Embrace Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.

Position Summary :

The Manufacturing Engineering Manager will be responsible for overseeing Instyllas manufacturing engineering efforts in the production of vascular embolic technologies and associated devices, ensuring product quality and scalability, driving continuous improvement initiatives, and supporting the companys long-term growth.

Job Responsibilities :

• Develop and implement operational strategies that align with business objectives and that enhance product consistency, reliability, and scalability
• Act as a subject matter expert on manufacturing technologies, processes, and methodologies
• Support all aspects of the medical device manufacturing process, ensuring efficient production and compliance with quality standards
• Manage the development, validation, and optimization of manufacturing processes, including design transfer from R&D to manufacturing
• Lead process transfers for both internal and external manufacturing
• Utilize data analytics to track performance, define metrics, and drive improvements
• Identify opportunities for process optimization and continuous improvement, reducing production costs while maintaining quality
• Manage partnerships with suppliers / vendors to maintain high-quality standards and timely deliveries
• Lead root cause analysis and corrective actions for production issues, product defects, customer complaints, and other technical challenges
• Lead sustaining engineering initiatives including this related to supply chain and component obsolescence issues
• Manage engineering projects, budgets, and resources to achieve business objectives
• Provide leadership, mentorship, and training to enhance team capabilities
• Maintain strict adherence to FDA, ISO 13485, and other regulatory requirements
• Foster and maintain a culture of collaboration, innovation, and continuous learning

Qualifications & Requirements :

Strong attention to detail

Working Conditions :