Senior Manager, Operations

The Senior Manager of Operations reports to the Vice President, Operations and is responsible for leading the day-to-day execution of manufacturing operations across internal production, contract manufacturing, production test, depot repair, field asset management, and facilities. This role is accountable for delivering safe, reliable, compliant, and scalable operations that consistently meet production schedules, quality standards, customer commitments, and business objectives.

As the operational leader, this individual will drive execution across both internal manufacturing and external contract manufacturing partners, ensuring production readiness, schedule attainment, material availability, operational responsiveness, and continuous improvement. The role requires strong leadership in managing contract manufacturing relationships, establishing performance metrics, proactively resolving operational issues, and ensuring timely responses to contract manufacturer inquiries to maintain production momentum and delivery commitments.

The Senior Manager will develop and implement the operational systems, processes, and governance necessary to support a growing medical device business. Responsibilities include establishing key performance indicators, driving operational discipline, improving manufacturing efficiency, strengthening supply chain coordination, and building scalable processes that support commercial growth and operational excellence.

Working in close partnership with the Vice President, Operations, this position will execute the Company's operational strategy while collaborating with Supply Chain, Manufacturing Engineering, Quality, Regulatory, Service, and Research & Development to support product introductions, manufacturing transfers, sustaining operations, and continuous improvement initiatives. The successful candidate will foster a culture of accountability, teamwork, data-driven decision-making, and continuous improvement while ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR), MDSAP, EU MDR, and all applicable regulatory and quality system requirements.

Lead by example by maintaining a hands-on approach to operations and fostering a culture of teamwork, accountability, and customer focus. Drive morning GEMBA walks and weekly with Customer Service and Marketing to ensure all requirements are covered. 

Demonstrate a willingness to assist on the production floor whenever needed, including supporting manufacturing, material movement, production testing, packaging, shipping, and other operational activities to meet business and customer commitments.

Provide operational support outside of normal business hours, when necessary, to resolve critical production issues, recover schedules, support product launches, or meet customer delivery requirements at the end of the month or quarter. 

Develop a clear understanding of the products, assist in the triage process when calls and complaints are received and drive equipment and consumable related issues to closure and assist with coherent and consistent fault identification for trend analysis.

• Bachelor’s degree in a scientific or technical field or equivalent experience.
• Minimum of 5+ years of medical device manufacturing management experience.
• Demonstrated ability to lead resources to achieve project goals.
• Experience with ISO 13485 compliant medical device projects and manufacturing environments.
• Working knowledge of Lean Manufacturing Principles
• Working knowledge of Quality System elements including Design Controls, Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), CAPA.
• Familiarity with Netsuite or similar ERP, Excel and ability to extract data and turn into clearly presented information. 
• Solid interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.
• Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities, and multiple deadlines.
• Working Project Management tools such as MS Project/Smartsheet, Excel, Word, etc.
• The ability to collaborate with all levels of management in a matrix environment required.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up-to 15 pounds at times
• Must be able to access and navigate each department at the organization’s facility
• On-site role with minimal flexibility to work remote.  
• Availability to travel up to ~10%, when necessary