Sr. Packaging Engineer

Position Description:

Sr. Packaging Engineer for Medtronic, Inc located in Jacksonville, FL. Responsible for design, development and support of package systems for both existing and new sterile products and non-sterile medical devices including components, assemblies, and labels from concept through implementation. Follow the product development process (PDP) to design, develop, and test a variety of containers used for protection, display and handling of medical devices. Establish equipment and packaging work flows for cell operating system (COS) production line. Navigate complexes of GMP, 21CFR 820, FDA quality assurance requirements for design and manufacturing and packaging, ISO 13885, ISO 11607 (Package Validation Testing) and ASTM (American Society of Testing and Materials) standards related to packaging. Utilize Test Method Validation [TMV], Statistical Process Control [SPC], Design of Experiments [DOE], Geometric Dimensioning & Tolerance [GD&T] and Corrective and Preventive Actions (CAPA). Conduct risk assessments to include DFMEA & PFMEA for packaging. Responsible for Process & equipment validations Process Validation (PV) & Installation Qualification, Operational Qualification, Performance Qualification (IQ/OQ/PQ). Position works a hybrid model and will be onsite in Jacksonville, FL - 3 days per week. Relocation assistance is not available. #LI-DNI.

Basic Qualifications:

Masters' Degree in Packaging Engineering, Industrial Engineering, Mechanical Engineering, or related engineering field and two (2) year of experience as a package engineer or related occupation in packaging engineering OR Bachelors' Degree in Packaging Engineering, Industrial Engineering, Mechanical Engineering, or related engineering field and five (5) year of experience as a package engineer or related occupation in packaging engineering. Must possess at least two (2) years' experience with each of the following: Product development process (PDP) to design, develop, and test a variety of containers used for protection, display and handling of medical devices; Establish equipment and packaging work flows for cell operating system (COS) production lines; GMP, 21CFR820, FDA quality assurance requirements for design and manufacturing and packaging, ISO 13885, ISO 11607 (Package Validation Testing) and ASTM (American Society of Testing and Materials) standards related to packaging; Test Method Validation [TMV], Statistical Process Control [SPC], Design of Experiments [DOE], Geometric Dimensioning & Tolerance [GD&T], CAPA; Conducting risk assessments to include DFMEA & PFMEA for packaging Process & equipment validations PV & IQ/OQ/PQ.

Position works a hybrid model and will be onsite in Jacksonville, FL - 3 days per week.

Salary: $114,500 to $141,600 per year