Manufacturing Engineer

Description

Job Title: Manufacturing Engineer

Location: Brecksville, Ohio

Employment Type: Full-Time

We are seeking a skilled Manufacturing Engineer to join our medical device production team. This role is critical in ensuring efficient, compliant, and high-quality manufacturing processes that meet regulatory standards and customer expectations. You will collaborate with cross-functional teams to maintain production equipment, optimize production processes, implement process improvements, maintain compliance with FDA and ISO requirements, and support facilities management oversight with service providers.

This role reports to the Manager, Operations Engineering and Facilities.

• Design, develop, and optimize manufacturing processes for medical devices.
• Implement and maintain Good Manufacturing Practices (GMP) and ISO 13485 standards.
• Collaborate with R&D, Quality Assurance, and Operations to ensure smooth product transfers from design to production.
• Develop and maintain process documentation, including work instructions, validation protocols, and risk assessments.
• Lead root cause analysis and corrective actions for production equipment and process issues.
• Support continuous improvement initiatives to reduce costs, improve efficiency, and enhance product quality.
• Ensure compliance with FDA regulations, ISO standards, and internal quality systems.
• Train production staff in new processes and equipment.
• Participate in equipment selection, installation, and qualification.
• Monitor and analyze production metrics to identify trends and opportunities for improvement.
• Provide technical support to manufacturing operations by resolving process and equipment issues, ensuring minimal downtime and consistent product quality.
• Assist with further establishment of preventive maintenance procedures and practices.
• Support CAPA investigations by performing root cause analysis (e.g., 5-Why, Fishbone) and identifying corrective and preventive actions.
• Be the primary contact for facilities management issues and resolution with service providers.

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering or related field.
• 3+ years of experience in manufacturing engineering, preferably in medical devices or regulated industries.
• Strong knowledge of FDA regulations, ISO 13485, and GMP.
• Experience with process validation, root cause analysis, and Lean/Six Sigma methodologies.
• Proficiency in CAD software and manufacturing process design.
• Excellent problem-solving, communication, and project management skills.

• Experience with automation and robotics in manufacturing.
• Knowledge of risk management tools (FMEA, PFMEA).
• Familiarity with ERP systems and data analysis tools.
• Experience troubleshooting equipment/process issues.
• Experience in production environment is preferred.

• Opportunity to work on innovative medical technologies that improve patient outcomes.
• Collaborative and growth-oriented work environment.
• Competitive salary, benefits, and professional development opportunities.

Up to $70,000.00