Sonendo, Inc. is a privately-held, venture-backed company with a unique mission to lead the transformation of endodontics through Sound Science®. We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity. We believe our success is based on always being at least one step ahead of our competitors, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision.
Reporting int our Chief Operations Officer, you will actively contribute to strategic discussions and strategy development while leading consumable production/operations. As a Director of Production you will be responsible for ensuring our consumable products meet customer demand and company revenue objectives. This leadership role will deliver high quality products while leading a compliant and continously improving high-volume manufacturing operations. As a Director of Production you will supervise and direct manufacturing personnel and processes to ensure safe, efficient, and on-time production schedules while adhering to FDA and GMP guidelines.
- Develop build schedules to support sales forecast. Will plan, direct, and assign duties to manufacturing personnel including scheduling and authorizing overtime as necessary to meet demand.
- Recruit, hire, train and retain manufacturing personnel ensuring compliance with Sonendo quality culture and essential expectations.
- Develop and lead Lean/6σ initiatives to continuously improve production efficiency, quality and cost in partnership with product development and supply chain
- Actively contribute to strategic discussions and strategy development to support the overall company goals and objectives.
- Partner with new product development cross functional teams to ensure a flawless design transfer that achieves key performance metrics and develop manufacturing procedures, inspection protocols, test methodologies.
- Support a Quality culture and ensure compliance with Quality System procedures and company policies.
- Review, coordinate and implement changes as appropriate including procedure updates.
- Participate in Risk Management activities. Provide technical expertise pertaining to the identification and mitigation of device manufacturing process risks.
- Troubleshoot production issues, assure machinery, equipment and production area is properly maintained to support production.
- Perform related duties as assigned by supervisor
- Bachelor's degree, BSME, BSEE or equivalent degree
- Must have a minimum of 10 years demonstrated experience in operations leadership with medical device companies that produce class 2 or 3 devices and in consumable products. Leadership in capital equipment production is a plus.
- Must have demonstrated Lean and 6sigma demonstrated capabilities and certification.
- Must have demonstrated change management experience.
- Must have demonstrated cross-functional team effectiveness, excellent interpersonal and written communication skills.
- Must have experience in high volume/ low mix production
- A demonstrated understanding of FDA and ISO requirements as they relate to medical device product design and manufacturing or regulated industry experience
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Position is primarily sedentary, and employee may be required to sit for extended periods of time. Standing, walking and meeting activities are required frequently throughout the workday. Employee must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.). A large portion of the day is spent communicating orally in person and by phone. Normal sight or corrected vision is required to read documents and use standard computer terminals. Must be able to lift and carry up to 25 lbs
Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization. If you are interested in applying for this position, please apply online.
No recruiters, please.
Sonendo, Inc. is an Equal Opportunity Employer