The Director of Manufacturing is responsible for all manufacturing assembly and manufacturing engineering activities for RefleXion’s groundbreaking radiotherapy devices. He/she leads a team responsible for executing best-in-class manufacturing assembly and test processes. This team will work closely with R&D and QA to transfer product to routine production and ramp a new factory to meet commercial launch requirements. Responsible for ensuring assembly and test processes 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 own Manufacturing strategy and be an evolving position in an exciting start-up company environment.
- Functional management of the Manufacturing Assembly and Manufacturing Engineering teams.
- Oversee manufacturing builds to ensure product quality & optimal resource utilization.
- Partner with R&D to transfer new products and processes to manufacturing that are stable and capable of meeting standards for product quality and cost effectiveness.
- Apply PFMEA risk assessment, implementation of process controls, and process and test method validations as appropriate to ensure product conformance.
- Ensure the factory layout and equipment are optimized for material flow and manufacturing efficiency.
- Oversee that assembly equipment, fixtures and tools are developed to meet quality, safety and performance objectives and are continuously improved through semi-automation, etc.
- Ensure all manufacturing documentation such as drawings, schematics, MPI’s, and BOM’s are accurate, streamlined and consistent.
- Work closely with materials management, QA and suppliers to assure that purchased material meets specifications.
- Transfer assembly & test processes to Field Service as applicable for installation, maintenance & repair.
- Identification and prioritization of design and process improvements needed for reliability, manufacturability and serviceability.
- Apply problem solving techniques to resolve proper corrective & preventative actions from NCR’s, CAPA’s and complaints.
- Ensure good engineering rationale is applied to all engineering reports, justifications and MTF’s to resolve ECO’s, NCMR’s, complaints, and CAPA’s.
- Own and drive cross-functional team projects for quality compliance, continuous improvements, outsourcing, etc. and present updates to executive staff.
- Work with Finance and Operations to establish appropriate cost standards, as well as budgeting for manufacturing capital and expense spending.
- BS required in Mechanical, Manufacturing or similar engineering discipline.
- 10+ years Manufacturing and/or Manufacturing Engineering management experience, 7+ years of experience with complex electromechanical equipment. Prior experience with radiotherapy or medical diagnostic systems preferred.
- Extensive Lean manufacturing knowledge such as visual factory, poka-yoke, 5S, waste elimination, and kaizen.
- Experience integrating and troubleshooting complex robotic electromechanical systems and related software.
- Technical knowledge across a variety of manufacturing processes: precision machining, PCA’s, cable assembly, manual assembly & semi-automation.
- Deep understanding of FDA QSR’s and ISO 13485.
- Experience performing PFMEA, IQ, OQ, PQ, PPQ, and TMV.
- Proven experience with data driven engineering methodologies such as DOE, GRR, SPC and 6 Sigma techniques.
- Significant experience interacting with suppliers to ensure product conformance, cost effectiveness and outsourcing initiatives.
- Knowledgeable of system packaging, shipping, installing and field service activities.
- Experience managing resources to meet financial budgets and executing cost improvement initiatives.
- 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 engineering 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%.