Senior Manufacturing Engineer

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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 Senior Manufacturing Engineer will be responsible for overseeing Instylla’s 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 company’s long-term growth.

• 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 optimization of manufacturing processes, including value improvement initiatives.
• 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.
• Lead root cause analysis and corrective actions for production issues, product defects, customer complaints, and other technical challenges.
• Lead sustaining engineering initiatives related to vendor changes, supply chain shifts, 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.

Supervisory Responsibilities

May be required to supervise Manufacturing Engineers and Technicians.

Qualifications and Education Requirements:

• Bachelor’s degree in manufacturing engineering, biomedical engineering, or other engineering discipline.
• Minimum 7 years of manufacturing engineering experience in the medical device industry with a minimum of 2 years of supervisory experience.

Knowledge/Skills:

• In-depth knowledge of FDA regulations, ISO standards, and relevant industry guidelines.
• Deep expertise in various manufacturing methodologies including LEAN, Six Sigma, CAPA, SPC, and other problems solving methods.
• Experience with Minitab or other statistical evaluation software.
• Experience scaling operations during periods of organizational growth, ideally in a start-up environment.
• Proven track record in leading transformational change initiatives.
• Strong understanding of regulatory impact on processes and alignment between functional operations and business strategy.
• CAD experience (preferably SolidWorks).
• Collaborative with a track record of building cross-functional partnerships.

Preferred Skills:

• Master’s degree or other advanced degree preferred.
• Experience in device manufacturing for peripheral vascular devices including implants.

Working Conditions:

• General office work with ability to lift up to 20lbs.
• Occasional travel required (10-20%).