Packaging Engineer II
Responsible for developing and validating packaging and labeling for New Product Introduction (NPI) projects. Design, develop, and test packaging used for the protection, display, and handling of medical device products. Support the selection, procurement, installation, and validation of packaging and labeling equipment. Conduct Process FMEAs and identify and implement packaging and labeling process improvement projects. Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Responsible for selecting and procuring packaging and labeling materials from vendors. Assist in designing package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsible for documentation management and an understanding of Good Manufacturing Practices (GMPs). Manage and create change requests within the document control system. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and support medical device manufacturing regulatory requirements, including FDA 21 CFR 820 and ISO 13485, 11607 and 20417. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Bachelor's or foreign equivalent degree in an Engineering field of study with at least 2 years of related professional engineering experience. In the alternative, will accept a Master's or foreign equivalent degree. Each alternative requirement must include an academic or industrial background in: (i) designing, developing, and testing packaging used for the protection, display, and handling of medical device products; (ii) conducting Process FMEAs and identify and implement packaging and labeling process improvement projects; (iii) documentation management and an understanding of Good Manufacturing Practices (GMPs); and (iv) supporting medical device manufacturing regulatory requirements, including FDA 21 CFR 820 and ISO 13485, 11607 and 20417. Employer will accept any suitable combination of education, training, experience.