Manufacturing Engineer Medical Devices (CNC Machining Focus)

Title: Manufacturing Engineer Medical Devices (CNC Machining Focus)

Location: Gainesville, FL (On-site)

Duration: Long Term Contract

Position Summary:

We are looking for an experienced Manufacturing Engineer with a strong background in CNC machining for precision medical device components. The candidate will be responsible for developing, optimizing, and validating CNC machining processes to meet stringent quality and regulatory requirements.

Key Responsibilities:

• Develop, program, and optimize CNC machining processes for medical device components.
• Select cutting tools, fixtures, and machining strategies to achieve tight tolerances and surface finish requirements.
• Collaborate with design engineers to review drawings and ensure manufacturability.
• Implement and maintain process controls to ensure consistent product quality.
• Troubleshoot machining issues and implement process improvements.
• Support process validation activities, including IQ/OQ/PQ, where applicable.
• Maintain compliance with ISO 13485, FDA QSR, and GMP standards.
• Train operators and technicians on CNC operation best practices.

Qualifications:

• Bachelor s degree in Mechanical, Manufacturing, or Industrial Engineering.
• 6-8 years of CNC machining experience in a medical device manufacturing environment.
• Strong knowledge of CNC programming (e.g., Mastercam, Gibbs CAM, or similar).
• Experience with precision machining of metals, plastics, or composites used in medical devices.
• Understanding of GD&T and blueprint reading.
• Familiarity with regulatory requirements for medical devices.