CathX Sr Mfg Engineer

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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 with FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

• Provide technical support for day-to-day manufacturing line operations, troubleshooting 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).
• Design tools and machines used to manufacture medical products.
• Review production program equipment, hardware, and tooling; make recommendations for servicing, specific repairs or replacement.
• Develop and optimize manufacturing processes for scalability, efficiency, and quality.
• Install new equipment and ensure correct operation; train others to operate new machinery.
• Maintain a general knowledge of new and developing manufacturing technology, equipment, and applications; apply this knowledge to recommend and implement new technology and processes.
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
• Communicate business‑related issues or opportunities to next management level.
• Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed are available and in good condition.
• Perform other duties assigned as needed.

• Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering or equivalent experience.
• Master's Degree in Mechanical Engineering, Industrial Engineering, or Biomedical Engineering is preferred.
• Five (5) or more years of relevant Engineering experience.
• Knowledge and experience in medical device manufacturing; catheter experience preferred.
• Competent experience with CAD software such as AutoCAD or Solid Works.
• Knowledge and experience in development processes and medical product documentation writing.
• Experience with statistical analysis and design of experiments (DOE) is preferred.
• Lean Manufacturing or Six Sigma certification or experience is preferred.
• Ability to use PC and associated software.
• In‑depth knowledge of thermoplastic materials and metals.
• Knowledge of Good Manufacturing Process (GMP) and Good Documentation Practice.

• 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 equipment.

Salary Range for this position: $113,000 - $136,000

Zeus Industrial Products, headquartered in Orangeburg, South Carolina, is the world’s leading polymer extrusion manufacturer and material science innovator. With over 50 years of experience in medical, aerospace, energy, automotive, fiber optics, and more, we set the bar high. Our products are cutting‑edge, our processes are unique, and our quality and customer focus are second‑to‑none. We are a leader in our field with strong relationships with customers and team members.

We pride ourselves on turning polymers into possibilities and on a mission to provide solutions, enable innovation, enhance lives. Our vision is to work together and do it better.