Position Description:
Sr. Packaging Engineer for Medtronic, Inc. located in Northridge, CA. Responsible for design, development, validation and support of packaging systems for both existing and new medical products and class-II/class-III devices including components, assemblies, and labels from concept through implementation; design package by utilizing Solidworks or Creo packaging design software; create component specification drawings and drive change mgmt. processes through ECOs (Engineering Change Orders). Perform packaging engineering in a regulated environment and release compliant packaging designs by navigating c-GMP (current Good Manufacturing Practices), 21CFR820, FDA quality assurance requirements for design and manufacturing and packaging; author package design validation plans, protocols, and work instructions; work with Quality to perform and support investigations on deviations and customer complaints related to packaging; conduct root cause analysis and implement CAPAs (Corrective Actions and Preventive Actions) 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; perform and/or support Process Validation (PV) by applying statistical techniques including Design of Experiment (DOE) methodology; coordinate packaging Design Validation (DV) activities and work with outside vendors on material selection. Develop EU-MDR (Medical Device Regulations) compliant packing for medical devices. Utilize Statistical Process Control (SPC); and author technical reports. *Position works a hybrid model and will be onsite in Northridge, CA – 3 days per week.
Basic Qualifications:
Requires a Master’s degree or foreign equivalent in Packaging Engineering, Industrial Engineering, Mechanical Engineering or related engineering field and two (2) years of experience as a packaging engineer or related occupation; or a Bachelor’s degree or foreign equivalent in Packaging Engineering, Industrial Engineering, Mechanical Engineering or related engineering field and four (4) years of experience as a packaging engineer or related occupation. Must possess a minimum of two (2) years of experience with each of the following: Medical Product or Packaging engineering compliant to c-GMP, 21CFR820, FDA quality assurance requirements, and EU-MDR; authoring test protocols; Solidworks or Creo packaging design software; DOE; DFMEA & PFMEA methodology; SPC, Root Cause Analysis, and CAPA; and creating component specification drawings and driving engineering change mgmt. process. *Position works a hybrid model and will be onsite in Northridge, CA – 3 days per week.
Salary: $113,100 to $141,600 per year
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