Sr. Packaging Engineer for Medtronic, Inc. Minneapolis, MN. Responsible for design, development, and support of package systems for both existing and new sterile implantable products (trans- catheter therapies) and non-sterile medical devices including components, assemblies, and labels from concept through implementation that include testing, sterilization, and manufacturing processes. Execute packaging engineering tasks for PDP s (Product Development Process) by defining customer needs, conducting VOX (Voice of Customers), coordinate design phase reviews, executing TMV s (Test Method Validations) and design V&V s (Validations and Verifications) in compliance with ISO 11607. Perform packaging engineering for a regulated environment and release package designs in compliance by navigating c-GMP (current Good Manufacturing Practices), 21 CFR 820, FDA quality assurance requirements for design and manufacturing and packaging. Author and execute package validations by testing protocols using ISTA (International Safe Transit Association), ISO 11607 (Package Validation Testing) and ASTM (American Society of Testing and Materials) standards related to packaging. Utilize Mechanical design software including SolidWorks, ArtiosCAD, PTC, and others, and statistical analysis software including MATLAB, Minitab, and others. Work with Quality to perform and support investigations on deviations and customer complaints related to packaging, conduct root cause analysis (RCA), and implement CAPAs (Corrective Actions and Preventive Actions) using Statistical Process Control (SPC) tools to ensure delivery of quality devices/products. Conduct risk assessments to include DFMEA & PFMEA (Design & Process Failure Mode Effect Analysis) for packaging, including packaging design and packaging process as required. Work with Quality and Operations to support Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology. Perform and/or support Process Validation (PV) and Equipment Qualifications (IQ/OQ/PQ) and author technical reports. Utilize pallet design software to include TOPS or equivalent. *Position is open to telecommuting anywhere in the United States. Apply at https://medtronic.wd1.myworkdayjobs.com/MedtronicCareers, Req. #R4239. No agencies or phone calls. Medtronic is an equal opportunity employer committed to cultural diversity in the workplace. All individuals are encouraged to apply.