Senior Manager, Operations

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced leader to oversee daily manufacturing execution, production testing, contract manufacturing, depot repair, field asset management, and facilities for a medical device operation. This role is critical in building operational infrastructure to support commercial growth and regulatory compliance.

Responsibilities:

• Direct and coordinate all aspects of daily manufacturing operations, including internal production, contract manufacturing, testing, packaging, and shipping.
• Oversee and manage relationships with contract manufacturers, set performance metrics, resolve operational challenges, and ensure production targets are met.
• Design and implement operational systems, processes, and governance frameworks to support business scaling and regulatory requirements.
• Facilitate cross-functional collaboration with supply chain, engineering, quality, regulatory, service, and R&D teams to drive operational excellence.
• Establish and monitor KPIs, driving continuous improvement in manufacturing efficiency and supply chain coordination.
• Support new product introductions, manufacturing transfers, and ongoing operations to ensure seamless transitions and sustained performance.
• Ensure strict compliance with relevant regulatory standards, including ISO 13485, FDA QSR, MDSAP, and EU MDR.
• Maintain and update quality management system documentation, including design history files, device master records, device history records, and CAPA processes.

Qualifications:

• Bachelor's degree in a scientific or technical field, or equivalent experience.
• 5+ years of management experience in medical device manufacturing.
• Experience working in ISO 13485 compliant manufacturing environments.
• Knowledge of Lean Manufacturing principles.
• Familiarity with ERP systems (such as NetSuite), MS Project, Smartsheet, and Excel.
• Strong understanding of design controls, DHF, DMR, DHR, and CAPA processes.
• Excellent interpersonal, project management, and communication skills.
• Ability to excel in a fast-paced, hands-on environment with shifting priorities.
• Ability to lift up to 15 pounds and navigate all facility areas.
• Availability to travel up to 10% as needed.

Published Category: Manufacturing & Technical Operations