We are looking for an experienced well-rounded individual to manage manufacturing, associated process improvements and overall operation of our active medical device manufacturing lines located in Kennesaw Georgia. The ideal candidate will be experienced in Manufacturing and Process Engineering of disposable medical devices and will be familiar with a variety of the field’s concepts, practices, and procedures. Responsibilities will include the establishment and optimization of manufacturing methods and processes for producing the organization’s disposable products to support rapid growth. This manager will be expected to conduct routine meetings as necessary with the manufacturing team, as well as management, to review manufacturing activities, delivery schedules, yields, etc. Ensuring high quality and maintaining a safe and positive work environment is a must. The manager will provide leadership and supervise the activities of manufacturing personnel engaged in all facets of the manufacturing function. Excellent written and verbal skills are critical for communication with the manufacturing team, other functions and divisional leadership.
- Manage day to day production of manufacturing line.
- Ensure smooth operation of facility, equipment and planning while meeting daily build targets.
- Develop, evaluate and implement process improvements to increase output and increase yields
- Motivate, oversee personnel, scheduling, professional development and hiring.
- Perform corrective and preventive actions (CAPA) in support of Quality.
- Develop and execute on a strategy for manufacturing capabilities to meet the current and future needs of the organization.
- Mentor and develop of the manufacturing team to meet the company needs.
- Facilitate the development of external subject matter expertise for process development, process characterization, validation, and manufacturing.
- Educate members of the team about the relationship between their work and achieving project and company objectives.
- Act as the lead technical person for laser fibers and possible other minimally invasive device manufacturing processes, equipment, and capabilities.
- Ensure that manufacturing engineering teams clearly understand their duties and obligations regarding both their job function and the project work to be completed
- Collaborate with other Managers and with other departments to maintain alignment of corporate objectives.
- Ensure that timecards are properly completed and approved on time
- Drive continuous improvement through trend reporting analysis and metrics management.
- Forecast future requirements and technical trends to drive improvements and offers new ideas and suggestions for improvement.
- Identifies and implements new practices and processes that are “best in class.” Use key performance measures to find a better way of doing things through Kaizen and other tools.
- Strong mechanical aptitude, previous experience designing and executing DOEs and equipment qualifications.
- BS in Engineering or equivalent technical education is required.
- 5-7 years manufacturing and process engineering experience with disposable medical devices.
- Planning, quality and supply chain knowledge in a regulated environment is a plus. 2 years supervisory experience
- Ability to work in a total Quality Management/Continuous Improvement Environment
- Desire to lead and develop the manufacturing management team at the facility.
- ISO 9000:2001, FDA GMP.
- Six Sigma/Lean Manufacturing methodology.