Director of Manufacturing

Summary


The Director of Manufacturing is a leadership position that will lead and represent the Manufacturing Department within the E2 organization. The Director will be responsible for scaling capacity, managing resources, and organizing the manufacturing space for all device production activities in support of commercial goals, engineering goals (prototypes and design verification builds), and clinical goals (clinical trials and demo devices).


PRINCIPAL DUTIES AND RESPONSIBILITIES

• Plan and coordinate resources and workflow to efficiently build devices in support of corporate and project goals. Provide status updates to the cross-functional teams.
• Track and report production metrics (yield, throughput, labor times) to assess manufacturing performance. Create and present manufacturing updates for management review.
• Recruit, train, and manage the Manufacturing team, consisting of assemblers, supervisors, a manager, technicians, and line support engineers.
• Manage responsibilities within the Manufacturing Department: line layout and workflow; critical spare equipment and equipment maintenance; kanban for supplies and components; CER monitoring; and lot history record reconciliation and closure.
• Revise and maintain production plans based on updates from SIOP meetings.
• Foster an inclusive culture of collaboration and teamwork with other departments and with outside suppliers.
• Support design control activities for transferring new devices from R&D to commercial manufacturing. Support Quality initiatives as required.

EXPERIENCE & QUALIFICATIONS

• Minimum of 5 years of experience as a Director of Manufacturing in the medical device industry.
• Experience scaling up manufacturing capacity for a Class 2 medical device at a startup company.
• Proven leadership experience managing assemblers, technicians, and engineers.
• Experience using ERP systems and Gantt charts.

EDUCATION REQUIREMENTS

• Bachelor's degree.

OTHER QUALIFICATIONS

• Strong written and verbal communication skills
• Excellent planning & decision-making skills.