R030
Located in Clearwater, FL
Pay: $110-115/K
Job Full Description
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.
Clearwater, FL
1380
1500 North McMullen Booth Road
Suite A3
Clearwater, FL 33759
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