Staff Packaging Engineer

Position can be located in Ogden, UT, Knoxville, TN, Irving, TX or Oregon

PURPOSE AND SCOPE:

The Staff Engineer works largely unsupervised. The Staff Engineer is involved in mentoring and teaching subordinate department or group members in order to improve their product knowledge, subject matter understanding, skills and productivity. The Staff Engineer also will be involved in setup of strategic activities, process improvements, and specific scientific studies for research and development. The Staff Engineer will often be a team leader of either internal Cross Technical Teams (CTT) or external Cross Functional Teams (CFT) and responsible to drive associated projects to completion. The Staff Engineer can also serve in a consultant role in multiple functional teams. The Staff Engineer functions as a Subject Matter Expert (SME) on the respective products and disciplines in which he/she is trained and expert in and may be assigned to manage various aspects of products from development, changes, improvements, replacements, etc.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Acts as a subject matter expert regarding the research and development of innovative disposable product packaging.
• Subject matter expert on secondary, tertiary and external packaging designs, usability, palletization design, transport simulation testing and qualification for domestic and international markets.
• Working understanding of ISO 11607-1, ISO 11607-2, and EU MDR requirements for medical device packaging.
• Working familiarity with statistical methodologies for the purposes of hypothesis testing in protocol development.
• Provide consultation and technical expertise to product owner and team regarding packaging design, development, test methods, test protocol, verification and qualification.
• Evaluates materials and supply chain to minimize unit cost.
• Single point of contact regarding ship testing for global teams.
• Supports new product design transfer into manufacturing, especially activities related to product packaging, including specification development, test method validation and automation for packaging.
• Participates and leads risk management activities related to product packaging.
• Develops and executes product shipping study protocols and final reports with coordination of internal and external transit test equipment/laboratory.
• Working knowledge and familiarity with ISTA and ASTM standards pertaining to product conditioning and analysis (e.g. ASTM D4169, ISTA 3A, ISTA 3E).
• Coordinates with regional distribution and logistics representatives to define appropriate ship testing and qualification conditions.
• Engages internal stakeholders and packaging material suppliers to develop new packaging for existing or new products, including detailed engineering specifications and drawings.
• Manages dangerous goods compliance and coordinates ADR testing.
• Hands-on involvement with fabrication of packaging prototypes for bag, pouch, foil, corrugated box, pallet, corner board, stretch wrap, slip sheet, buckle and other material or medium used for product packaging and transportation.
• Selects appropriate materials for each application.
• Selects test lab and may coordinate test activities.
• Develops and validates new techniques and test methods related to product integrity testing when neither ISO nor ASTM standards are commonly available to the specific needs of Fresenius disposable products.
• Establishes and maintains ship test procedures and work instructions.
• Uses computerized tools to aid in product packaging integrity analysis, load strength maximization and compression ratio studies, e.g. CAPE, TOPS and other common industry software for packaging and transportation design/analysis.
• Uses hand tools, small power tools and test equipment.
• Stays current on new/revised/upcoming regulations in the industry.
• Aligns with global counterparts outside of immediate team. Ensures knowledge transfer and transparency on technical topics and industry trends.
• Keeps abreast of latest technologies, processes, and industry trends.
• Keeps abreast of ISO, ASTM, USP, etc. standard revisions for area of responsibility.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EXPERIENCE AND REQUIRED SKILLS:

• Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree preferred.
• Minimum 8 - 12 years' related experience
• Extensive experience with ship testing per ASTM D4169 or ISTA 3A & 3E.
• Experience with liquid and/or dry products.
• Experience with medical device and/or pharmaceutical product packaging.
• Extensive experience with protocol development, execution, & reporting.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.