Director of Operations

Job Description & Responsibilities

The Director of Operations is responsible for leading and coordinating cross-functional programs that drive on-time, on-budget execution of manufacturing and operations initiatives in a regulated medical device environment.

• Partner with Manufacturing Engineering and Operations leadership to optimize production processes, capacity, and throughput.
• Support process validations (IQ/OQ/PQ), equipment qualification, and production line readiness for new and existing products.
• Drive continuous improvement using Lean Manufacturing, Six Sigma, Kaizen, and Value Stream Mapping methodologies.
• Career readiness reviews and production hand-off activities from development to commercial manufacturing.
• Onsite warehouse employee oversight.

Quality & Regulatory Compliance

Ensure all program activities comply with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and applicable EU MDR requirements.

• Support Design Transfer, Design Controls, and Design History File (DHF) deliverables in coordination with R&D and Quality.
• Drive engineering change orders (ECOs), CAPAs, and nonconformance resolutions through to closure with operational impact assessments.
• Partner with Regulatory Affairs to ensure program plans align with 510(k) submission timelines, post-market surveillance, and labeling requirements for Class II devices.
• Support internal, supplier, and external audits (FDA, Notified Body) as the Operations program lead.

Leadership & Communication

Facilitate cross-functional core team meetings, steering committee reviews, and executive program updates.

• Influence without direct authority across engineering, quality, supply chain, and external partners.
• Translate technical and regulatory complexity into clear, actionable communication for both technical teams and senior leadership.
• Mentor junior team members and contribute to building program management best practices and tools across the organization.