Job Title: Manufacturing Engineer Location: Gainesville, FL Type: Contract Experience: 3 - 5 Years Work Arrangement: Onsite Job Description We're seeking a highly capable Manufacturing Engineer to support operations in a regulated medical device manufacturing environment. This role focuses on validation, process improvement, and cross-functional collaboration to ensure quality, compliance, and efficiency across production lines. Key Responsibilities Protocol Review & Compliance: Review IQ/OQ/PQ protocols and reports to ensure compliance with regulatory and procedural standards.

Process Audits & Documentation: Conduct audits of manufacturing processes, identify gaps, and update QMS documentation accordingly.

Process Optimization: Design and execute Design of Experiments (DoE) to optimize parameters for CNC Machining and DCM. Define and document robust operating windows.

Validation Execution: Perform or support validation execution, including sampling, data collection, and reporting for IQ, OQ, PQ.

Statistical Analysis: Use statistical tools (e.g., Minitab, JMP) to assess process capability, variability, and trends.

Change Management: Lead documentation and execution of change control related to process or equipment modifications.

Continuous Monitoring: Ensure validated processes remain in control by implementing monitoring systems and corrective actions as needed.

Cross-functional Collaboration: Partner with Quality Engineering and other departments to support manufacturing, resolve issues, and contribute to new product development.

Medical Device Support: Provide hands-on support for medical device assembly lines, including troubleshooting, risk analysis, and readiness assessments.

Technical Activities: Support activities like materials testing, process studies, verification and validation, specification development, and documentation.

Qualifications Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field

Experience in CNC Machining and DCM within medical device manufacturing

Familiar with FDA regulations, ISO 13485, and GMP standards

Proficient in statistical analysis tools (Minitab, JMP)

Hands-on experience with QMS and ERP systems

Knowledge of IQ/OQ/PQ/TMV processes

Strong communication, documentation, and problem-solving skills

Comfortable working with cross-functional teams in a fast-paced environment