Director of Manufacturing Operations

4 weeks ago


Hazelwood, Missouri, United States BioFire Diagnostics Full time

Job Summary:

The Director of Manufacturing Operations will oversee the planning and direction of departmental functions at the St. Louis Operations site to ensure achievement of corporate goals and objectives. This role is responsible for the manufacture and maintenance of instrument production and refurbishment through oversight of multiple teams. Key responsibilities include providing technical expertise and quality support, identifying and justifying projects for capital funding, and delivering projects on time and budget. Additionally, this position will coordinate and oversee the implementation of engineering projects related to cost improvements and new product introductions, ensuring cooperation within and outside the department at both local and global levels.

Key Responsibilities:

• Manage Manufacturing: Oversee the manufacturing and refurbishment groups to ensure customer satisfaction, deliver forecasted product on schedule with no errors or nonconformities, and maintain high employee morale.

• Manage and Maintain Production Equipment: Ensure that the manufacturing areas are maintained to continuously manufacture and refurbish product, successfully manufacturing product to meet demand and improve efficiency to reduce the COGS.

• Product Transfer: Manage the transfer of new products from Research to Manufacturing, validating new processes to meet regulatory requirements and ensuring necessary procedures are in place to order parts / materials to meet market demand.

• CAPA Investigations: Manage and provide technical expertise to projects related to investigating failures in current product production or testing processes, recommending and monitoring the implementation of preventive actions and process improvements resulting from these failure investigations.

• Cost Improvement and Risk Management: Manage and provide technical expertise to justify and implement cost improvement projects in Operations, directing projects that are conducted to qualify secondary vendors in order to reduce production and vendor-related risks.

• Finance: Ensure adherence to Departmental budgets, including the maintenance of COGS, headcount, controllable, non-controllable expenditures and capital investments.

Requirements:

• Bachelor's degree required, preferably in a technical field, with 10+ years of manufacturing experience.

• Advanced degree is preferred.

• Thorough knowledge of instrument production and related business activity, and the development and deployment of manufacturing systems.

• Thorough knowledge of applicable regulatory requirements (FDA, ISO, OSHA, etc.).

• Understanding of the Company's quality system.

• Requires demonstrated strengths in leadership, interpersonal skills, project management, creative thinking, problem solving, and communication.

• Familiarity with LEAN manufacturing concepts.



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