Manufacturing Engineer

Job Title:

Manufacturing Engineer

Ohio

6 12+ Months

The Manufacturing Engineer will support manufacturing operations, process development, process improvements, and production activities within a regulated medical device environment. This role will work closely with Engineering, Quality, Operations, and R&D teams to ensure manufacturing processes are efficient, robust, and compliant with applicable medical device requirements.

• Support manufacturing processes and production operations for medical device products
• Develop, improve, and optimize manufacturing processes to improve quality, efficiency, and productivity
• Support equipment qualification, process validation, and implementation of new manufacturing processes
• Develop and maintain manufacturing work instructions, SOPs, and process documentation
• Troubleshoot production and process issues and perform root cause analysis
• Support CAPA, non-conformance, and continuous improvement activities
• Participate in process changes, engineering changes, and product transfers
• Develop and maintain process documentation, including process flow diagrams, work instructions, and manufacturing specifications
• Collaborate with Quality, R&D, Operations, Supply Chain, and external suppliers
• Support production line layouts, equipment installations, and manufacturing equipment improvements
• Ensure manufacturing activities comply with FDA, ISO 13485, and applicable quality system requirements

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related field
• 5+ years of manufacturing engineering experience within the medical device or other regulated manufacturing industry
• Experience with manufacturing process development, optimization, and troubleshooting
• Knowledge of process validation and equipment qualification activities
• Experience with root cause analysis, CAPA, and non-conformance investigations
• Working knowledge of FDA requirements and ISO 13485
• Strong problem-solving, communication, and cross-functional collaboration skills

• Experience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies
• Experience with IQ, OQ, and PQ validation activities
• Experience with medical device assembly, machining, injection molding, or automated manufacturing processes
• Knowledge of PFMEA, process flow, control plans, and statistical process control
• Experience supporting new product introduction and design transfer activities

The hourly rate for this position is $38-50 per hour.

This is a contract position and does not include employer-provided benefits.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable law.

Applicants must be authorized to work in the United States.