What are the responsibilities and job description for the Manufacturing Process Engineer position at Zeus Company, Inc.?
Job Description
This position is responsible for aspects of the process design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).
Responsibilities
- Designs fixtures, tools, and machines used to manufacture products.
- Oversees the development of new processes, methods, and production controls.
- Maintains knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes.
- Perform engineering and data analysis for activities such as validations and engineering studies including DOEs and root cause investigations.
- Generate and review process documentation including but not limited to Manufacturing Process Instructions (MPI), Bill of Materials (BOM), and Lot History Records (LHR).
- Generate and execute Engineering Change Orders (ECO).
- Identify and implement process improvements to increase quality, capacity, and efficiency, while reducing waste.
- Monitor process performance using Statistical Process Control (SPC), and other engineering principles.
- Communicate with customers to understand project needs and set expectations for deliverables.
- Reviews production program equipment, hardware, and tooling; make recommendations for repairs or replacement.
- Installs new equipment and ensures that it operates correctly; train others to operate new machinery.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Performs other duties assigned as needed.
- The position does have supervisor responsibilities, is responsible for performance management and the hiring of the employees that are designated under their supervision.
Qualifications
COMPENTENCIES :
To perform the job successfully, an individual should demonstrate the following competencies :
