The Manufacturing Manager leads a team responsible for implementing best-in-class product manufacturing, assembly and test for RefleXion’s groundbreaking radiotherapy devices. This manufacturing team will work closely with NPI and Quality to build product in pilot and routine production. The manager will ramp a new factory to meet aggressive build plans for the introduction of a new product. Responsible for ensuring production staff and manufacturing tools are capable to meet company objectives for product quality, delivery and cost. The successful candidate will be a strong functional leader with proven experience applying Lean manufacturing and continuous improvement practices, as well as medical device quality system compliance, to complex electromechanical capital equipment. This role will serve as the primary manufacturing manager for the factory and will be an evolving position in an exciting start-up company environment
- Drive a culture change from development centered manufacturing systems to low volume high mix production manufacturing
- Lead, hire, train, motivate, and make performance corrections for (10+) technicians and production leads
- Execute & maintain production schedules aligned with the company sales and operations plan
- Ensure product quality and compliance to FDA & ISO regulations
- Attain operational goals for yield, efficiency, and delivery
- Ensure employee safety and compliance to applicable Federal, State and company safety regulations
- Drive efforts to continuously improve quality and costs using the principles of lean manufacturing and operational excellence: lean flow, takt time, standardization, kanban, 5S, cross-training, etc
- Create, apply, and monitor performance metrics to personnel, products, and methods.
- Recognize & solve problems affecting production including scheduling, staffing, quality, supply chain, EH&S, facilities and equipment.
- Partner with R&D, QA, and Supply Chain to launch new products and improvements to the current product.
- BS required in Mechanical Engineering, Manufacturing or similar engineering discipline.
- 8+ years functional Manufacturing experience,
- 5+ years of experience with complex electromechanical equipment.
- Prior experience with radiotherapy or medical diagnostic systems preferred.
- 3+ years of experience in a functional management role.
- Experience integrating and troubleshooting complex robotic electromechanical systems and related software.
- Technical expertise across a variety of manufacturing processes: precision machining, PCA’s, cable assembly, manual assembly & semi-automation.
- Understanding of FDA QSR’s and ISO 13485.
- Extensive Lean manufacturing knowledge such as visual factory, poka-yoke, 5S, waste elimination, and kaizen.
- Demonstrated ability to be a proactive and collaborative leader in a dynamic start-up environment.
- Excellent interpersonal and communication skills across all levels of the organization.
- Ability to mentor manufacturing personnel and cross-functional resources on best practice manufacturing principles and the application of solid engineering judgement.
- Strong attention to detail and organizational skills.
- Willingness to travel up to 10%