SetPoint Medical’s Operations Manager is responsible for overseeing and optimizing 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. The Operations Manager will work closely with cross-functional teams to implement strategies that improve efficiency, reduce costs, and enhance overall performance while ensuring compliance with quality standards and regulations. The Operations Manager will play a crucial role in driving SetPoint Medical's success by ensuring efficient, compliant, and cost-effective operations. This is an exciting opportunity for an experienced operations professional to make a significant impact in a mission-driven, innovative medical device company. This position will report to the Vice President of Operations.

This position is in office, Monday - Friday, reporting to company headquarters in Valencia, CA. 

Job 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.
• Perform other duties as assigned.

Minimum Qualifications 

• 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.

Company Description:

SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases with its neuroimmune modulation platform.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.