Position Summary:
The primary purpose of this position is to plan and direct departmental functions (Instrument Manufacturing, Engineering, Instrument Refurbishing) at the St. Louis Operations site to ensure achievement of the corporate goals and objectives of the worldwide bioMerieux organization. This position is responsible for the manufacture and maintenance of instrument production and refurbishment through oversight of multiple teams. In addition, this position provides technical expertise and quality support through implementation of projects and continuous improvement activities; identifies and justifies projects for capital funding, and delivers the projects on time and budget. This role also requires coordinating and overseeing the implementation of engineering projects related to cost improvements and new product introductions, ensuring cooperation within and outside the department at both the local and global levels. Finally, this position is responsible for developing and maintaining an engaged, motivated, and skilled production workforce.
The job requires the management of activities related to the manufacturing, process engineering, project management, validation, design control, troubleshooting, transfer from R&D to Manufacturing, and continuous improvement of equipment and processes to manufacture instruments and devices. This must be accomplished with high efficiency and high quality in order for these products to be competitive in the marketplace. The industry is highly regulated and requires compliance with FDA, ISO, IVD, Medical Device, and other pertinent regulations and directives.
Primary Responsibilities:
- Manage Manufacturing – Manage the manufacturing and refurbishment groups to ensure customer satisfaction. Deliver the forecasted product on schedule with no errors or nonconformities. Maintain the complex manufacturing process and minimize loss. Maintain high employee morale, drive cooperation between departments at both local and global levels, and drive employee career development.
- Manage and Maintain Production Equipment – Ensure that the manufacturing areas are maintained so that production can continuously manufacture and refurbish product. End result: Successfully manufacture product to meet demand and improve efficiency to reduce the COGS.
- Product Transfer – Manage the transfer of new products from Research to Manufacturing. Validate the new processes to meet regulatory requirements and ensure the necessary procedures are in place to order parts/materials to meet market demand. End result: Successful market introduction of new, high-quality products that meet all relevant and applicable regulatory requirements.
- CAPA Investigations – Manage and provide technical expertise to projects related to investigating failures in current product production or testing processes. Also direct projects that address customer complaints related to product performance. Recommend and monitor the implementation of preventive actions and process improvements resulting from these failure investigations. End result: Implementation of successful corrective actions that address process-related customer complaints and help reduce scrap and production process-related failures by building robustness into the manufacturing process and product design.
- Cost Improvement and Risk Management – Manage and provide technical expertise to justify and implement cost improvement projects in Operations. Direct projects that are conducted to qualify secondary vendors in order to reduce production and vendor-related risks. End result: Successful implementation of cost-improvement projects that help achieve the corporate objective of reduction in cost of goods sold.
- Finance – Ensure adherence to Departmental budgets. This includes the maintenance of COGS, headcount, controllable, non-controllable expenditures, and capital investments. End result: Ensure that the corporate financial objectives are met.
Education, Skills, & Experience:
- 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.