Manufacturing Engineer

Intellectt INC; Kentucky; On-site; USD 52,000 - 69,000; Full time

Job summary

Intellectt INC seeks a Manufacturing Engineer to support operations, process development, and improvements in a regulated medical device setting. You will work with Engineering, Quality, Operations, and R&D to ensure efficient, robust processes that meet medical device requirements.

The role requires a Bachelor's degree in engineering and 5+ years of experience, with knowledge of process validation, equipment qualification, CAPA, and FDA/ISO 13485.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering or related field.
• 5+ years of manufacturing engineering experience in medical devices or regulated manufacturing.
• Experience with process development, optimization, and troubleshooting.
• Knowledge of process validation and equipment qualification activities.
• Experience with root cause analysis, CAPA, and non-conformance investigations.
• Familiarity with FDA requirements and ISO 13485.

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.

Skills

Manufacturing engineering

Problem-solving

Cross-functional collaboration

Process development

Root cause analysis

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial/Biomedical Engineering

Tools

FDA requirements

ISO 13485

Process validation

CAPA investigations

Job description

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.