Responsible for directing and overseeing Instrument Manufacturing, Reagent Manufacturing, and Rotor Manufacturing. Achieves operational goals including productivity, quality, cost, delivery, safety and colleague engagement requirements while maintaining strict adherence to FDA and other government and local regulations. Ensures the proper operational controls, metrics, procedures, and personnel are in place to effectively grow the organization for financial and operational efficiencies.
Duties and Responsibilities
Assists Manufacturing site leader in creating the three to five-year vision and pipeline of activities to grow the organization.
Staff, train, manage, develop and provide leadership to department managers/supervisors in Production, Calibration and Quality Control in the application of practical operations planning and control techniques toward higher levels of performance while providing an environment that encourages change and teamwork.
Sets performance objectives for the manufacturing organization that focuses on short-term, as well as long-term business objectives.
Reviews staffing requirements, personnel allocations, and organizational structure to not only meet today’s requirements, but those of future growth.
Initiates capital requirements for all manufacturing areas and ensures on time delivery and cost of the project.
Understands and educates staff on balancing personnel needs and process improvements with managing budgetary expenses to meet overall financial targets. Develop and implement capacity plan across all teams to assure that sales goals are supported.
Ensures production goals are achieved including productivity, quality, cost, delivery, safety and morale requirements
Develop and achieve annual and quarterly operating budgets to meet company objectives with risk mitigation plans in place.
Evaluates challenges and opportunities to meet the Sales and Operation Plans on a monthly basis.
Responsible for year on year standard time reductions through continuous and quality improvement initiatives.
Evaluate and implement meaningful metrics across the organization, as well in other cross-functions that impact the manufacturing team.
Ability to create cost models for projects that clearly reflect return on in investment and financial impact for cost improvement projects.
Ensure strict adherence to FDA and other government and local regulations.
Assess efficacy of processes, align with standard operating procedures and apply enhancements.
Continuously evaluates performance through metric reviews and adjusts as required to meet goals.
Other duties as assigned
Extensive experience as a Director in Manufacturing overseeing multiple product lines/families.
In depth knowledge of diverse business functions/processes such as Supply Chain, Quality, Regulatory, Finance, Customer Service and Design Transfer.
Proven track record of building successful teams and facilitating progressive organizational change for in a growing company.
Demonstrated performance of consistently achieving and exceeding financial goals.
Ability to work in a fast-paced environment through utilization of exceptional organizational skills, the aptitude to multi-task and balance complex priorities.
Excellent interpersonal and communication skills, both verbal and written.
Demonstrated ability to lead people, manage internal/external customer satisfaction and get results through others.
Experience and expertise in high volume manufacturing using manual to automated processes including manufacturing processes, techniques and workflow in a repetitive production environment.
Thorough knowledge of GMP, FDA and ISO requirements in the Medical Device/diagnostic field.
Extensive experience in Lean, SPC, Six Sigma manufacturing techniques, FDA compliance, and process improvement.
Thorough knowledge of finance as it relates to budgeting including monitoring and controlling quarterly annual expense budgets, as well as operational absorption for both labor and materials.
Understands and mitigates financial risks to the top and bottom line of P&L through cross-functional collaboration.
Excellent analytical, project management and problem solving skills.
Advanced computer skills using MS Office, Change Control Software (preferably Veeva Vault), Product Lifecycle Software and thorough knowledge and understanding of all aspects of SAP as it relates to P2M and M2D.
Education and Experience
BS/BA degree in Business, Engineering, or related field with 10+ years medical device production management, preferably in the diagnostics industry.