CathX Senior Manufacturing Engineer

Zeus Company Inc. • Arden Hills, MN • 8h ago

Job Description The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. Additionally, the engineer supports daily manufacturing operations in a sustaining role, providing technical expertise to resolve issues and maintain production efficiency. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Responsibilities Provide technical support for day-to-day manufacturing line operations, troucleshooting equipment and process issues. Implement and lead continuous improvement projects to enhance productivity, quality, and cost-effectiveness. Lead process validation activities (IQ/OQ/PQ) in compliance with regulatory requirements. Manage line transfer projects, ensuring smooth transition and qualification of equipment and processes. Apply structured problem-solving methodologies (e.g., 5 Whys, Fishbone, DMAIC) to identify root causes and implement effective corrective and preventive actions (CAPA). Designs tools and machines used to manufacture medical products. Reviews production program equipment, hardware, and tooling; makes recommendations for servicing, specific repairs or replacement. Develop and optimize manufacturing processes for scalability, efficiency, and quality. Installs new equipment and ensures correct operation; trains others to operate new machinery. Maintains a general 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. Qualifications Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering or equivalent experience based on management discretion is required. Master's Degree in Mechanical Engineering, Industrial Engineering, or Biomedical Engineering is preferred. Must have five (5) plus years' relevant Engineering experience Knowledge and experience in medical device manufacturing is required. Catheter experience preferred. Competent experience with CAD software such as AutoCad or Solidworks is required. Knowledge and experience in development processes and in medical product documentation writing is required. Experience with statistical analysis and design of experiments (DOE) preferred. Lean Manufacturing or Six Sigma certification or experience preferred. Ability to use PC and associated software is required. In-depth knowledge of thermoplastic materials and metals is required. Knowledge of Good Manufacturing Process and Good Documentation Practice.COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies: Values: Integrity, Accountability, Teamwork, Innovation Excellent verbal and written communication skills Ability to work independently 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 Hands on technical knowledge with manufacturing equipmentSalary Range for this position: $113,000 - $136,000 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 Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjUxNjkxLjEwNTA2QHpldXNjb21wYW55Y29tcC5hcGxpdHJhay5jb20

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