Packaging-Engineer-R-D

JOB DUTIES & RESPONSIBILITIES: – Interprets standards and FDA requirements for device packaging and validations.
– Ensures all packaging validation, testing and supporting discussions comply with operating procedures.
– Works cooperatively with other departments to gather and incorporate customer inputs on packaging design.
– Interprets and applies sterilization requirements/standards to packaging design and validation. – Operates various test equipment, interprets test data, and reports results for each validation/verification.
– Works cooperatively with process development, quality, manufacturing, regulatory and marketing to ensure project success.
– Research & acquire production material and equipment related to packaging configurations.
– Able to recognize, plan, and request for capital costs associated with packaging.
– Train production operators of new processes and procedures.
– Coordinate documentation of work instructions for new packaging configurations.
– Create material/equipment specifications.
– Ability to manage time and resources effectively through good organizational skills and effective use of problem solving skills.
– Ability to work independently as well as on teams to perform root cause analysis and provide solutions to the root cause.
– Coordinate projects related to packaging configurations between production facilities.
– Ability to interact with personnel at all levels of the company, as well as agents of other companies, standards organizations, and government.
Other duties, as assigned.
EDUCATION & EXPERIENCE: – BS in Engineering or equivalent.
– Minimum of two years demonstrated experience with product packaging design, development, and/or validation is required preferably in the Medical Device industry.
– Minimum of two years demonstrated experience with product packaging design.
– Excellent verbal and written communication skills.
– Attention to detail.
– Working knowledge of project management.
– Excellent organizational and documentation skills.
– Self motivation and the ability to work independently.
– Ability to interact with personnel at all levels of the company, as well as agents of other companies, standards organizations, and government.