Manufacturing Engineer

Job Title: Manufacturing Engineer
Location: Ohio
Duration: 6 12+ Months
Contract : W2

Job Summary:
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.

Responsibilities:
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

Required Qualifications:
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

Preferred Qualifications:
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

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

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

Equal Opportunity Employer:
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 Check:
Background checks may be conducted in accordance with applicable law.

Work Authorization:
Applicants must be authorized to work in the United States.