Purpose and Scope
The purpose of this role is to support manufacturing activities related to Monteris Disposable Devices.
Primary Organization Responsibilities
- Lead daily manufacturing activities/support such as root cause analysis, , continuous improvement initiatives, resolving line down issues, equipment qualification, and execution of formal studies.
- Act as subject matter expert for disposable manufacturing lines and processes
- Oversee transfer plan and execution of new manufacturing lines
- Utilization of statistical methods to inform and drive data-based decisions around process improvements, validations, etc.
- Serve as the voice of manufacturing and core team member on projects for new product development and quality initiatives.
- Provide support into complaint investigations, CAPAs, non-conformance events, and any other disposable product related issues
- Develop manufacturing processes, procedures, and associated process validations
- Write test protocols, execute testing, analyze data, and write engineering reports.
- Perform other duties as directed or assigned
- Bachelor’s degree in engineering or related field
- 5+ years’ experience in medical device development, testing, quality, manufacturing, or other relevant discipline
- Possess strong organization, engineering, analytical and communication skills
- Statistical knowledge and ability to create/analyze data within statistical based software
- Possess the ability to be able to build product as required
- Be extremely comfortable with accountability and being challenged to improve both their organization and the company’s performance against quality goals