Design Assurance Engineer
Zeus Company Inc.

Job Description

Job Summary

The Design Assurance (DA) Engineer works as an integral part of the CathX Medical Quality team and is responsible for designing and manufacturing high quality medical products. The Design Assurance Engineer is the leading voice of quality in new product development, technology transfers, and process development. Responsible to provide Design Assurance Engineering support for Build to specification and design controls projects as detailed below:

Responsibilities

• Establish design verification protocols and reports with input from the project manager and manufacturing engineering. Perform independent verification of test data and analyze results.
• Draft or provide input on test methods, test method validation, and general testing requirements to ensure that standards, regulations and guidance document criteria are met.
• Support process validation and technology transfer studies for special processes to improve CathX Medical quality assurance methodology.
• Develop master validation plans and reports based on input from customers' and project teams.
• Review and provide input on calibration, preventive maintenance, IQ/OQ, PQ and software validation protocols for inspection, measuring, manufacturing, and testing equipment.
• Support all aspects of risk management including hazard analysis, Design FMEA and Process FMEA for build to specification and design controls projects.
• Obtain and gain agreement on any special quality, test, and certification requirements in cooperation with the project team and assure overall agreement between CathX Medical and customer drawings and specifications for Build to specification and design controls projects.
• Draft and execute design of experiments (DOE), Test methods, TMV, and capability studies with the input and support of the manufacturing engineer and project manager.
• Work as a part of a core team with R&D, Project manager, Manufacturing engineering and business development, as required, in new product introduction for Build to specification and design controls projects.
• Perform statistical analysis of test data and inspection results for new product introduction.
• Promote a culture of compliance to company procedures.

Qualifications

• One or more years' experience in quality engineering, R&D/ project engineering or equivalent relevant experience in a biomedical engineering discipline.
• BS degree in science, engineering, or manufacturing or equivalent experience or certifications.
• Demonstrated expertise in quality concepts, practices, and procedures.
• Ability to work collaboratively with customers.
• Strong interpersonal communication skills are required.
• Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, test method validations, prepare statistical quality control data and develop statistical designed experiments.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Ability to travel as necessary.
• This role is an in-person role due to the nature of support internal engineering and manufacturing teams.

Salary range for this position: 90k - 115,000/annual

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?
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