Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, the first capsule-based system for preparation-free, colorectal cancer screening. Utilizing innovative ultra-low dose X-ray and wireless communication technologies, our capsule generates information on the contours of the inside of the colon as it passes naturally. This information is used to create a 3D map of the colon, which allows physicians to look for polyps and other abnormalities. Designed to improve the patient experience and increase the willingness of individuals to participate in recommended colorectal cancer screening, C-Scan® removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness, and sedation.
If you are passionate about leading excellence in developing organizations and willing to be part of Medical Devices life-saving company which will influence millions throughout the world, we are offering a unique and a great opportunity for talented people.
We are looking for manufacturing engineering manager to join our company.
- Manages the engineering group including new product development, continuation engineering, process development and represents the engineering department on the leadership team.
- Determines project assignments, schedules and deliverables deadlines to meet defined timelines
- Multidisciplinary products/system, engineering background and experience
- Leads and executes on projects, as needed
- Oversees the evaluation, selection, and application of new design methodologies and technologies that drive new product/process development
- Manages and executes the C-Scan process, ensuring compliance to regulatory requirements
- Manages Operation design and development activities, including prototypes, design documentation, tooling and verification and validation testing.
- Oversees the creation of process design proposals, specifications, and reports to support products applications and requirements.
- Oversees the engineering lab and machine shop
- Responsible for the design of test methods and equipment to evaluate designs (component through final device) and the development of accurate and complete test protocols for component, sub-assembly, and final assembly testing.
- Manages and supports improvement activities in conformance with established programs and objectives per the Quality Management System
- Provides leadership, guidance and resource allocation to technology development, NPI, R&D, and Sustaining Engineering
- Responsible for the performance appraisal, development, and training of engineering staff
- Develops and manages Engineering budget
- Participate in the development and implementation of LEAN business process strategies and tactical execution.
- Act as an internal cross-functional expert providing guidance and consultation supporting the Check-Cap LEAN Transformation.
- Leader for deployment of needed LEAN knowledge including the deployment of LEAN tools, processes and mental models, i.e.; Kaizen, 5S, value stream mapping, etc.
Qualified candidates must meet the following requirements:
- Bachelor’s degree (or higher) in Mechanical, Electronic, Biomedical, or related Engineering field.
- 6-10 years of experience as an engineering lead in medical device manufacturing and Project/program management
- Experience with medical device quality regulations including: GMP, ISO 13485/9001
- Excellent, detail-oriented verbal and written communication skills
- Experience managing direct and indirect reports.
- Manufacturing launch, scale up and process improvement
- Six Sigma black belt, master black belt is a plus.
- Experience in Lean Manufacturing, Kaizen events, and continuous improvement techniques.