Manufacturing Engineer

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