To develop and maintain product packaging & labeling for new and existing products for Cardiac Assist.
- Design and update product packaging (e.g., Instruction for Use booklets, product labels, pouches and shelf cartons) for medical device products.
- Coordinate approval and implement graphic design of pre-printed product labeling both internally and through suppliers.
- Works with computer based labeling software to create in-house printed labels incorporating device graphics, industry compliant bar codes and database information.
- Assists in the preparation of validation protocols for heat sealing equipment and packaging related material changes.
- Develop and release project related documentation including project schedules, design change documentation and design history files.
- Interacts with QA, Marketing, Engineering, Manufacturing and Regulatory Affairs personnel to facilitate the design, development and release of fully compliant product packaging and labeling.
- Assist in the development of sterile barrier systems and protective packaging for new and existing products in compliance with ISO 11607.
- Work with outside translation services to create multilingual labeling and specifications for packaging components including IFUs, labels, cartons, and patient record inserts.
- Develop, write, and execute sealing validations, package performance (ship test) protocols, and package aging qualifications.
- Perform data analysis on sealing processes using statistical tools.
- Troubleshoot package sealing and labeling processes.
- Bachelors' degree in Engineering/technical discipline or equivalent
- Previous experience in medical device or pharma industry within packaging a plus
- Excellent oral and written communication skills
- Team player who can work proactively with all staff members to achieve project goals.
- Must be detail oriented with ability to manage multiple assignments with deadlines.
- Working knowledge of computer based programs such as MS Office applications (Word, Excel, Project) are required. Adobe Suites, and/or Solid Works software experience is a plus.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
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