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 tools and machines used to manufacture products.
Reviews production program equipment, hardware, and tooling; makes recommendations for repairs or replacement.
Oversees the development of new processes, methods, and production controls.
Installs new equipment and ensures that it operates correctly; trains others to operate new machinery.
Prepares operations manuals for new or existing equipment.
Maintains knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes.
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
Bachelor's Degree in Mechanical Engineering is required.
Master's Degree in Mechanical or Biomedical Engineering is preferred.
Must have five (5) plus years' relevant Engineering experience
Knowledge and experience in catheter design is required.
Experience with CAD software such as AutoCAD or Solidworks is required.
Knowledge and experience in development processes and in documentation writing is required.
Experience with statistical analysis and design of experiments (DOE) preferred.
Ability to use PC and associated software is required.
In-depth knowledge of material and metals is required.
Knowledge of Good Manufacturing Process and Good Documentation Practice.
Competencies: To perform the job successfully, an individual should demonstrate the following competencies:
Ability to manage tight timelines and changing priorities
Excellent problem-solving techniques
Proficient with Microsoft office applications
Skilled at providing technical leadership on cross-functional teams
About Us
Zeus Industrial Products, headquartered in Orangeburg, South Carolina, is the world's leading polymer extrusion manufacturer and material science innovator. More than 50 years of experience in medical, aerospace, energy, automotive, fiber optics, and more allows us to set the bar high.
Zeus is a great place to work. Expectations are high; our work is meticulous and very precise. Zeus offers an opportunity to join a very successful, family-oriented team. Our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none. We are a leader in our field and have great relationships with our customers and team members. Many of our team members are the best at what they do in the world. Our customers are leaders in their fields. Our products help save lives.
Continuous Improvement is a way of life at Zeus. Successful candidates will have a desire and ability to take our manufacturing process to the next level. Expectations are high; our work is meticulous and very precise. You must possess the ability to work independently; and the desire to learn a variety of skills. The ability to communicate clearly is imperative, as is the ability to manipulate data using various software packages.
At Zeus, what we do matters, and we pride ourselves in "Turning polymers into possibilities." Expectations are high; our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none.
Our employees and our customers are at the center of everything we do. Those relationships have been built on a foundation that is supported by our Mission and Vision:
Our Mission: Provide Solutions - Enable Innovation - Enhance Lives
Our Vision: Working Together - Doing It Better
Zeus is an exciting, innovative company that offers competitive pay and a great benefits package. As we continue to push the boundaries of polymer science, we're constantly in need of new ideas, new expertise, and new team members. Are you ready to join us? Content