Contract Medical Device Manufacturing Process 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

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.