Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Florida

Duration: 12 Months

Job Summary:

We are seeking a skilled Manufacturing Engineer to support production and process improvement initiatives for a leading medical device manufacturer. The ideal candidate will drive manufacturing efficiency, product quality, and regulatory compliance across production operations.

Key Responsibilities:

• Develop, optimize, and validate manufacturing processes for Class I, II, or III medical devices.
• Lead and support equipment selection, installation, IQ/OQ/PQ validation, and preventive maintenance.
• Partner with R&D, Quality, and Regulatory teams to ensure smooth new product introduction (NPI).
• Conduct root cause analysis (RCA) and implement corrective/preventive actions (CAPA).
• Support non-conformance investigations and continuous improvement activities.
• Generate and update SOPs, process documentation, work instructions, and technical reports.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
• Utilize Lean, Six Sigma, and other methodologies to drive cost savings and process enhancements.

Qualifications:

• Bachelor’s degree in Mechanical, Biomedical, or Manufacturing Engineering or related discipline.
• 2–5 years of experience in a manufacturing engineering role within the medical device industry.
• Experience with validation protocols (IQ/OQ/PQ), equipment qualification, and process development.
• Knowledge of FDA and ISO 13485 regulations is required.
• Proficiency with CAD software (SolidWorks/AutoCAD), ERP/MES systems, and Microsoft Office.
• Strong analytical and communication skills; ability to work cross-functionally.