Sterilmed Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Packaging and Labeling Development Engineer, located in Plymouth, MN.
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We are offering a fantastic opportunity for an engineer to join our team and play a vital role in the development and improvement of new products and processes throughout their life cycle. In this position, you will have direct involvement with new product development, as well as collaborating with our Research & Development team to ensure the validation of packaging configurations and labeling contents in line with FDA requirements.
As a successful candidate, you will work closely with members of our design and sustaining teams, forming an integral part of a core team striving to achieve project goals. Your responsibilities will encompass supporting two teams: firstly, improving the quality and compliance of our existing products and designs, and secondly, leading the vital testing for the development and validation of new packaging configurations and labels.
At Sterilmed, we are recognized as authorities in medical device reprocessing, focusing primarily on high-complexity devices such as electrophysiology and imaging catheters. This role will involve some travel between our manufacturing, distribution, and receiving sites located in the metro-Minneapolis area. A Day in the Life Develop, design, and validate packaging and labeling per requirements Lead and coordinate validation of package components, labeling components, and packaging processes Partner with design team to deliver packaging components for R&D and packaging projects Evaluate new package concepts and technologies Identify processing needs, develop packaging specifications, procure equipment and materials Lead process improvement and task teams, supporting continuous improvement efforts Investigate and implement corrective/preventive actions for manufacturing processes Author, revise, and provide support for production work instructions Support regulatory partners in approval efforts and Master Data Management processes Ensure compliance with regulations, policies, procedures, and staff Health, Safety, and Environmental guidelines if applicable Required Bachelor's degree in engineering field (Biomedical, Packaging, Manufacturing, Mechanical, Industrial, etc.) Minimum of 4 to 6 years packaging engineering responsibilities in ISO13485/GMP environment Prior experience in the medical device industry is preferred May require up to 10% travel Preferred Proficiency in Microsoft Office and excellent technical written and oral communication skills. Experience with statistical analysis, including DOE, FMEA, QSR, process capability studies, and validation methodology, with knowledge of statistical software. Familiarity with ASTM and other packaging standards, working within an ISO structured quality system. Strong planning, multi-tasking, and project management skills with a consistent record of completing projects on time and accomplishing goals. Ability to work independently as well as part of a team, leading multiple priorities in a fast-paced environment. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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