Sr. PKG Engineer Position Available In Alachua, Florida

Sr.

PKG Engineer Department:

Manufacturing Engineering Employment Type:

Full Time Location:

Gainesville, FL Reporting To:

Norbert Nasi Description The Sr. Packaging Engineer will provide Packaging Engineering and related support for New Product Development Projects and for Packaging Operations. The Sr. Packaging Engineer exercises independent judgment in Packaging engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among cross functional groups, and has broad expertise or unique knowledge in Packaging Engineering. Key Responsibilities Areas of involvement include package process and design, regulatory submissions, Design History File creation and maintenance, package/case evaluation, validation, and testing, supplier support, quality control and complaint evaluation. Contribute to the design input requirements for medical-device packaging components through consultation with end users Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components. Study and recommend improvements to existing packaging and labeling and processes. Identify, analyze and recommend new technologies or materials for specific applications. Support tiered management initiatives, inclusive of metric setting, monitoring, and equipment up time goals Assist in the resolution of manufacturing or quality related issues Maintain packaging bills of material and DHF/DMR documentation Assure timely and effective project completion according to the project plan and budget. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team. Maintain and improve upon existing packaging systems. Consult with vendors, as required, regarding the technical aspects of packaging design and attributes. Prepare and submit written and oral communications that describe packaging and instrument case design concepts, attributes and performance, and project status. Review and approve drawings, designs, & specifications for feasibility and manufacturability. Use control processes such as Change Management Procedures to implement process changes. Define and execute package and product (where necessary) testing and validation protocols – Gage R&R, Equipment Qualification, Recipe Qualification, Distribution, Stability, Test Method Validation, Usability, etc. Participate in the establishment of goals, project plans and resource requirements. • Design, develop, and implement changes to new and existing product labels, patient implant cards, Patient Information Leaflet, and instructions for use (IFUs) for use in manufacturing. Develop strategies for continuous improvement of the Labeling program and procedures. Act as subject matter expert for the business with respect to labeling design, requirements, and implementation and labeling software and effectively collaborate on labeling changes. Know and apply the Quality System and any appropriate Federal and International standards (ISO, ASTM, AAMI, etc). Assist and support other project, tasks, responsibilities, employees, teams, and sales personnel as necessary.

Skills Knowledge and Expertise Education:

Bachelor’s Degree from an accredited institution required

Experience:

Minimum of 7 years medical device packaging. Relevant product development experience in other areas may be considered. Must understand theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, packaging methods, packaging evaluation, packaging materials, and technical writing. Minimum of 5 years with Good Manufacturing Practices & Lean Manufacturing in the Medical device industry preferred. FDA Part 820 Quality Systems Regulations in the medical device industry preferred. Experience in the writing of validation/verification plans for various types of packaging testing, including but not limited to Gage R&R, development and execution of

IQ/OQ/PQ

documents (Equipment Qualification), Recipe Qualification, Distribution, Stability, Test Method Validation, Packaging Usability.

Functional/Technical Knowledge, Skills and Abilities Required:

Practical working knowledge of medical-device packaging, packaging and/or case evaluation techniques/methods, engineering drawing interpretation, packaging and/or case manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and/or instruments and the materials and methods used in their packaging or sterilization cases. Must be creative and able to independently apply theoretical technical principles to packaging and process design. Must have knowledge of various software packages including Microsoft Office, CAD, and Statistical Analysis applications (e.g. Minitab). Prioritize and manage several projects simultaneously.