Function: Manufacturing Engineering / Packaging Operations Department / Reports to / Location: To be assigned
Role purpose
Act as the manufacturing process expert for packaging operations. Support robust, efficient packaging processes and coordinate production-side requirements with packaging design, quality, validation, and operations teams.
Key responsibilities
Translate approved packaging specifications and process requirements into equipment settings, work instructions, line setup, and production controls.
Troubleshoot packaging equipment and process issues; coordinate trials, changeovers, and implementation of approved improvements.
Support packaging process risk assessments and qualification or verification activities with the responsible quality and validation functions.
Review packaging defects, process data, and production feedback to identify causes and recommend corrective actions.
Coordinate with packaging design and suppliers to assess manufacturability, materials, equipment compatibility, and transfer readiness.
Baseline qualifications
Engineering degree required.
2-5 years of medical device experience required.
Experience with production equipment, process documentation, and structured troubleshooting.
Strong cross-functional communication and attention to detail.
Preferred experience
Experience with packaging operations for regulated products and packaging process qualification.
