Senior Medical Device Packaging Engineer

JobDiva, Inc.; Madison (WI); On-site; USD 70,000 - 110,000; Full time

Job summary

JobDiva, Inc. in Madison, WI is seeking a Packaging Engineer to lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).

You will collaborate across Manufacturing, Quality, Regulatory, and Engineering to ensure compliant, efficient packaging operations. The ideal candidate holds a related engineering degree and has experience in regulated environments, with strong problem-solving and project leadership skills.

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, 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.

Skills

Lean Manufacturing

Six Sigma

Cross-functional collaboration

Problem solving

Project leadership

Education

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

Job description

JobDiva, Inc. in Madison, WI is seeking a Packaging Engineer to lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).

You will collaborate across Manufacturing, Quality, Regulatory, and Engineering to ensure compliant, efficient packaging operations. The ideal candidate holds a related engineering degree and has experience in regulated environments, with strong problem-solving and project leadership skills.