CathX Sr Mfg Engineer

The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices.

Requirements

• 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 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.

Benefits

• Competitive pay
• Great benefits package