Manufacturing Engineer

Top Job

Located in Clearwater, FL

Salary: $110-115/K

Direct Hire Opportunity

$110-115/K

The Senior Manufacturing Engineer will lead the development, optimization, and validation of manufacturing processes for Class I and Class II medical devices in accordance with ISO 13485 and FDA 21 CFR 820 requirements. This position provides strategic and hands-on leadership to drive manufacturing excellence, cost efficiency, and compliance across all production lines. The role requires a proven technical leader who can initiate and manage complex projects, mentor junior engineers, and collaborate cross-functionally to achieve business and operational goals.

 

Essential Duties and Responsibilities:

• Lead cross functional manufacturing initiatives to enhance process efficiency, cost-effectiveness, and quality.
• Serve as a technical leader and subject matter expert on process validation, design transfer, and continuous improvement.
• Champion Lean and Six Sigma methodologies to reduce waste, increase yield, and improve product flow.
• Mentor and train other engineers and technicians in best practices for manufacturing and validation.
• Develop, validate, and implement new manufacturing processes and equipment in compliance with IQ/OQ/PQ requirements.
• Establish and maintain manufacturing documentation including work instructions, control plans, and inspection criteria.
• Oversee production readiness activities for new product introductions (NPI) and design transfer projects.
• Lead Engineering Change Orders (ECOs) related to manufacturing changes, product configurations, or process improvements.
• Ensure adherence to ISO 13485, FDA QSR, and internal Quality Management System (QMS) standards.
• Support internal and supplier audits and lead root cause investigations with CAPA implementation.
• Partner with Design Engineering to ensure manufacturability (DFM/DFA) during product development.
• Work closely with Quality, Supply Chain, and Operations to ensure consistent product quality and production efficiency.
• Provide technical input for supplier selection and qualification processes.
• Identify, justify, and procure new manufacturing equipment to support automation and scalability.
• Coordinate preventive maintenance programs and ensure equipment remains validated and compliant.
• Utilize statistical tools and data analysis to monitor key process indicators and implement corrective actions.

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