Manufacturing Engineer

Position: Manufacturing Engineer

Location: Gainesville, FL (Onsite)

Job Type: Contract/FTE

Required Qualification & Skills:

• Bachelor s or master s degree in mechanical engineering, Biomedical Engineering, or related field.
• 5+ years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.
• Strong understanding of FDA, ISO 13485, and GMP requirements.
• Proficiency in statistical analysis tools (e.g., Minitab, JMP).
• Experience with QMS systems and documentation practices.
• Excellent analytical, problem-solving, and communication skills.
• Experience working in QMS and ERP systems.
• Experience with IQ/OQ/PQ/TMV preferred.
• Worked with cross-functional teams.
• Collaborate with Quality Engineering to provide manufacturing support.
• Responsible for providing manufacturing engineering support to specific projects, including change analysis, risk analysis, and manufacturing readiness.
• Should be experienced in medical device manufacturing assembly lines.
• Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
• Need to conduct qualification, verification, and validation activities to produce medical devices.
• Need to be responsible for completing engineering work and contributing to new product development teams and product support, typically including the following activities: technology development, testing of materials or products, preparation of specifications, Six Sigma, process studies, process improvements, and report preparation.
• Participate in cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
• Work with CFT teams in troubleshooting problems on the production floor.