Process Engineer, Medical Devices

Process Engineer

12-month contract

Onsite in Cary, IL

• Develop and refine process formulations, manufacturing methods, and quality controls to ensure compliance with industry regulations and company standards.
• Identify, recommend, and implement process improvements, modifications, and documentation updates to enhance efficiency, consistency, and product quality.
• Review product development requirements to evaluate compatibility with current processing methods, cost implications, and scheduling constraints.
• Integrate equipment and material capabilities into production workflows to meet process module and technology target specifications.
• Conduct root cause analysis and troubleshooting for process deviations, ensuring timely resolution and continuous improvement.
• Collaborate with cross-functional teams, including R&D, quality, and manufacturing, to ensure seamless product development and commercialization.
• Maintain accurate technical documentation and contribute to process validation efforts.

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field) or equivalent practical experience.
• Minimum of 2 years of experience in process engineering, preferably in a medical device or regulated manufacturing environment.
• Strong understanding of process validation, quality systems, and regulatory requirements (ISO 13485, FDA, GMP, etc.).