Senior Medical Device Packaging Engineer - Lean & Validation

Katalyst-Healthcares-; Springfield (MO); On-site; USD 65,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Packaging Engineer to support and improve packaging operations for medical device manufacturing in Springfield, Missouri. You will lead packaging process development, equipment qualification, and IQ/OQ/PQ validation activities.

Collaborate with Manufacturing, Quality, Regulatory, and Engineering teams to resolve issues and drive continuous improvement. Applicants should have a degree in packaging or a related engineering field and experience in

Qualifications

• Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
• Engineering experience (or equivalent advanced degree and relevant experience).
• Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.

Responsibilities

• Lead packaging process development, IQ/OQ/PQ, and equipment qualification for medical device manufacturing.
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues and drive improvements.
• Perform root cause investigations, develop CAPA solutions, maintain technical documentation, and drive Lean/Six Sigma based enhancements.

Skills

Lean Manufacturing

Six Sigma

Root cause investigations

CAPA solutions

Cross-functional collaboration

Project leadership

Technical communication

Problem-solving

Education

Bachelor's Degree in Packaging Engineering/Packaging Science/Mechanical/ Chemical Engineering

Job description

Responsibilities:

• Responsible for supporting and improving packaging operations for medical device manufacturing. Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA and quality system requirements.
• Perform root cause investigations, develop CAPA solutions, maintain technical documentation, support packaging equipment and process validation, and drive operational excellence using Lean Manufacturing and Six Sigma methodologies. Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills are required.

Requirements:

• Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
• Engineering experience (or equivalent advanced degree and relevant experience).
• Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.