Manufacturing Engineer

Position: Manufacturing Engineer Location: Gainesville, FL (Onsite)

Experience : 8 - 10 Years Duration: 12+ Months (Contract)

We’re hiring experienced Manufacturing Engineers for a high-impact contract role at a leading medical device facility in Gainesville, FL. If you have a strong background in IQ/OQ/PQ, process validation, and manufacturing within regulated environments, this is a solid opportunity.

Key Responsibilities:

Review and ensure compliance of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in medical parts manufacturing

Lead and support validation activities across CNC/DCM operations

Conduct process audits, identify improvement opportunities, and optimize production workflows

Use statistical tools (Minitab, JMP) to analyze data and drive process efficiency

Collaborate with quality, design, and production teams to troubleshoot issues

Ensure compliance with FDA, ISO 13485, and GMP standards

Must-Have Skills:

8 to 10 years of experience in medical device manufacturing, with a focus on CNC/DCM processes

Deep understanding of quality management systems, ERP platforms, and change control procedures

Proven track record in executing and documenting process validation (IQ/OQ/PQ, TMV)

Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field