Operations Director

24 hours ago

Valencia, California, United States SetPoint Medical Full time

Job Summary:

SetPoint Medical is seeking an experienced Operations Director to oversee and optimize the day-to-day operations of our medical device manufacturing facility. The ideal candidate will have a proven track record of managing production, logistics, and supply chain in a regulated ISO 13485 environment.

Key Responsibilities:

  • Develop and implement operational strategies aligned with SetPoint Medical's goals and objectives.
  • Oversee production processes, ensuring that quality standards are met, and production targets are achieved in compliance with ISO 13485 requirements.
  • Manage logistics and supply chain activities, including inventory management, and distribution.
  • Monitor and analyze key performance indicators (KPIs) to identify areas for improvement and implement necessary changes.
  • Collaborate with cross-functional teams to optimize operational processes and ensure compliance with regulatory requirements.
  • Develop and manage budgets for operational activities, ensuring cost-effectiveness and efficiency.
  • Manage and motivate a team of operations staff, providing guidance, training, and support to ensure optimal performance.
  • Identify and implement process improvements and automation opportunities to enhance operational efficiency.
  • Oversee the operation and maintenance of the cleanroom facility, ensuring compliance with ISO 14644 standards and other relevant regulations.

Requirements:

  • Bachelor's degree in business administration, operations management, or a related field. MBA is a plus.
  • Proven experience of at least 10 years in operations management, preferably in a medical device manufacturing or regulated production environment.
  • Strong understanding of operations management principles, including lean manufacturing, Six Sigma, continuous improvement, and ISO 13485 quality management systems.
  • Knowledge of health and safety regulations and quality management systems.
  • Ability to work under pressure and manage multiple priorities in a fast-paced environment.

Skills and Abilities:

  • Excellent analytical, problem-solving, and decision-making skills, with the ability to be hands-on and data driven.
  • Strong leadership, communication, and interpersonal skills, with the ability to motivate and develop a team and collaborate effectively with cross-functional teams.
  • Proficient in using ERP systems and other relevant software tools.
  • Ability to adapt to changing priorities in a fast-paced, dynamic startup environment.
  • Passion for improving patient outcomes and a deep commitment to the company's mission and values.

Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Able to occasionally assist with inventory room activities such as lifting to 35 pounds at times.

Location:

  • Company Headquarters in Valencia, CA.
  • This position will travel up to 10 percent.

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