Sr. Packaging Engineer

Position Description:

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 from anywhere in the United States.

Basic Qualifications:

Masters' Degree or foreign equivalent in Packaging Science or Packaging Engineering or related field; and two (2) years of experience as a packaging engineer, manufacturing engineer, or related occupation for medical devices. Or alternatively Bachelors' Degree or foreign equivalent in Packaging Science or Packaging Engineering or related field; and five (5) years of experience as a packaging engineer, manufacturing engineer, or related occupation for medical devices.

Must possess at least two (2) years' experience with each of the following: Pallet design software; Sterile trans-catheter therapies and non-sterile medical device packaging design, development, testing, sterilization & manufacturing processes. SolidWorks, ArtiosCAD, PTC or equivalent software, and statistical analysis software; GMP, 21CFR 820, ISO 11607, and ASTM standards related to design and manufacturing and packaging; Risk assessments, DFMEA & PFMEA for packaging. Process & equipment validations, and IQ/OQ/PQ; SPC, RCA, and CAPA

Position is open to telecommuting from anywhere in the U.S.

Salary: $121,400 to $141,600 per year

#LI-DNI