Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related field.
Engineering experience or an advanced degree with relevant experience.
Preferred experience in Medical Device, Healthcare, Pharmaceutical, or similar regulated environments.
Familiarity with packaging validation and manufacturing processes.
Understanding of quality systems and regulatory requirements.
Responsibilities
Support and enhance packaging operations for medical device manufacturing.
Lead packaging process development and equipment qualification efforts.
Collaborate across teams to address production challenges and improve processes.
Conduct root cause investigations and implement CAPA solutions.
Maintain technical documentation and validate packaging equipment and processes.
Benefits
Opportunity to work in a highly regulated and impactful industry.
Engagement with cross-functional teams for diverse learning and growth.
Involvement in continuous improvement initiatives, enhancing skills in Lean and Six Sigma.
Exposure to cutting-edge packaging technologies in medical devices.
Full 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.
