Director of Operations

 

GENERAL DUTIES AND RESPONSIBILITIES:

  • Develop overall near and long term strategy for the operations organization that insures availability of high quality product that meets sales forecast and demand.

  • Develop programs, projects, goals, and metrics to lead the manufacturing organization to optimize operational performance.

  • Develop, manage and execute cost reduction and productivity improvement plans.

  • Develop policies, practices, and procedures that allow for efficient identification and resolution of production problems.

  • Develop and implement processes, technologies, and tooling needed to achieve a lean production model.

  • Manage supply chain including price negotiation, ordering, expediting, labeling, inventory and issuing parts.

  • Coordinate inspection, packaging, labelling and sterilization for commercial product.

  • Manage the maintenance of a well-organized stock inventory and product quarantine areas with appropriate segregation of all stages of materials.

  • Maintain and monitor inventory levels in accordance with the JIT philosophy.

  • Support company goals and objectives, policies and procedures

  • Develop, track and publish production performance metrics, i.e. capacity forecast, cycle time, scrap rate, yields, non-conformances, inventory and corrective actions.

  • Deliver products on time meeting quality and cost requirements.  Ensure there is an optimum production process with regards to equipment, manpower, and supply chain.

  • Accountable for compliance of manufacturing operations with specifications, SOPs, FDA regulations, EPA regulations, ISO regulations and NDAs.

  • Improve product quality and prevent customer complaints through proactive interaction with internal and external suppliers including appropriately defined component specifications, manufacturing process instructions and inspection requirements.

  • Utilize collective data from customers to enhance product quality.

  • Assess and implement product/process changes when needed to ensure quality and manufacturability is maintained.

  • Hire, develop, and manage operations team – fulltime and contractors.

  • Establish and maintain an environment that encourages teamwork and promotes employee safety.

 

 

EXPERIENCE/EDUCATION REQUIREMENTS:   

  • Bachelor's degree in an engineering or related discipline is required. Advanced degree preferred.

  • 10+ years’ experience in operations leadership role with multi discipline responsibilities (production, purchasing, etc.) in medical device industry.

  • Strong understanding of FDA and ISO medical device manufacturing requirements required.

  • Ability to manage all activities of department.

  • Ability to create, interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting.

  • Software application skills required including Solidworks and Microsoft Project.

  • Strong interpersonal, problem solving, communication and management skills are required.

  • Six Sigma certification considered a plus.