Company Summary:

Centese, Inc. is a fast-paced start-up medical device company developing products to improve outcomes for patients undergoing heart and lung surgery. The first product, Thoraguard, is a fully automated chest tube and chest drainage system at the intersection of patient-centric outcome improvement and digital medicine. We are building a team of multidisciplinary experts passionate about positively impacting the lives of others through technological advancement.

Job Summary:

We are seeking a highly experienced and strategic-minded Director of Operations to lead our manufacturing operations for medical devices. The successful candidate will be responsible for overseeing the entire production process, managing the production team, and implementing efficient manufacturing strategies to drive operational excellence. This role requires a deep understanding of medical device manufacturing, quality control standards, and regulatory compliance, along with strong leadership skills and the ability to drive continuous improvement initiatives.

Key Responsibilities:

Manufacturing Strategy:

• Develop and implement a comprehensive manufacturing strategy aligned with the company's overall objectives and growth plans
• Collaborate with cross-functional teams, including engineering, quality assurance, and supply chain, to ensure effective coordination and integration of manufacturing processes

Operational Leadership:

• Lead and manage the Production Manager, fostering a culture of excellence, collaboration, and continuous improvement
• Monitor and analyze key performance indicators (KPIs) to evaluate operational efficiency, identify areas for improvement, and implement corrective actions as needed
• Implement best practices and lean manufacturing principles to optimize productivity, reduce costs, and enhance overall operational performance

Manufacturing Execution:

• Oversee the entire manufacturing process, from raw material procurement to final product assembly, ensuring adherence to quality standards, regulatory requirements, and delivery timelines
• Collaborate with the Quality Manager to develop and implement robust quality control processes and ensure compliance with relevant regulations and standards
• Drive initiatives to improve process efficiency, capacity planning, inventory management, and waste reduction while maintaining a high level of product quality

Supply Chain Management:

• Create and/or review and approve purchase orders in alignment with budget and production needs
• Develop and maintain strong relationships with suppliers, ensuring timely delivery of raw materials and components while managing costs and inventory levels
• Monitor and mitigate potential supply chain risks, such as disruptions or shortages, to maintain continuity of production operations
• Develop long-term sourcing strategies
• Establish and manage a relationship with a freight forwarder to complement or supplement outsourcing vendors logistics capabilities

Continuous Improvement:

• Foster a culture of continuous improvement by promoting innovation, identifying operational bottlenecks, and implementing process enhancements
• Lead and support cross-functional teams in implementing lean methodologies and process reengineering to drive efficiency and reduce waste

Required Qualifications:

• Bachelor's degree in operations management or a related field
• Proven experience (at least 6 years) in operations management
• Demonstrated success in leading and managing manufacturing operations, including supervising teams and driving operational excellence
• Excellent analytical, problem-solving, and decision-making skills, with a data-driven mindset
• Strong leadership abilities, including the ability to inspire and motivate cross-functional teams, and foster a collaborative work environment
• Experience in implementing lean manufacturing principles and process improvement methodologies
• Exceptional communication skills, both written and verbal, with the ability to effectively interact with internal stakeholders, external partners, and regulatory agencies

Preferred Qualifications:

• A master's degree
• Experience within the medical device manufacturing industry
• Strong knowledge of medical device manufacturing processes, quality control, and regulatory compliance (e.g., FDA, ISO standards)

Salary Range: $98K - $120K

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Paid Time Off
• Sick Leave
• Short & Long-Term Disability
• Life Insurance
• 401(k)
• Wellness Program

MUST PASS A CRIMINAL BACKGROUND CHECK