Manufacturing Manager

Company Overview : Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and transform eardrum repair surgery into an office-based procedure.

Job Summary : We are hiring a Manufacturing Manager to drive, manage, and fully execute the overall manufacturing effort for the Company's medical devices with the objective of maximizing growth and meeting the device demand plan. This senior, hands-on position reports to the CEO and works closely with multifunctional team members, combining technology transfer and medical device manufacturing expertise with operations and leadership acumen to guide and execute timelines that drive products through production readiness and into the hands of customers. An ambitious candidate with a track record of successful manufacturing within controlled environments and operations leadership who wants to lead small teams, mentor junior members, and set the standard for medical device manufacturing in a fast-growing startup would thrive in this role.

Key Responsibilities

Manufacturing Operations :

• Scale manufacturing in support of commercial readiness, including management of near-term growth and controlled environment scale-up.
• Manage day-to-day manufacturing operations including in-house production, supply chain management including managing contract manufacturers, inventory control, and distribution.
• Direct procedures and policies to achieve production schedules, product standards, compliance with safety standards, and operational and capital costs.
• Participate in creating tech transfer plans, validation protocols, work instructions, and implementation of novel processes.
• Manage manufacturing area in accordance with and ensure compliance with FDA cGMP, ISO 13485, and other regulatory requirements for medical device manufacturing.
• Implement best practices for production planning and execution, supply chain management, and inventory / distribution operations.
• Align, direct, and manage manufacturing and support departments within the site to ensure product capacity and quality requirements are met while meeting manufacturing schedules.
• Directly supervise production operators, technicians, and material planners with direct responsibility for the decisions, actions, and performance of the team.
• Oversee supply chain and manage our contract manufacturers and suppliers.
• Oversee equipment maintenance, calibration, and validation to ensure optimal performance and compliance.
• Develop budgetary evaluations on manufacturing costs to be used in early project / product feasibility and throughout the product lifecycle.
• Identify, develop, and implement process improvements to enhance product quality, reduce costs, and improve efficiency.
• Participate and recommend strategy and long-term planning of the facility's operations (including equipment and technology upgrades) to ensure continued success.

Leadership & Team Development :

Experience and Qualifications

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