Packaging & Design Engineer

Cryoport, Inc.-posted 3 months ago
Irvine, CA
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The Packaging & Design Engineer plays an integral role on the Product Development Team, which assists life science and regenerative medicine clients across all phases of clinical and commercial development with a spectrum of offerings aimed at understanding, quantifying and reducing cold-chain supply chain, logistics and/or packaging risks. The Packaging & Design Engineer will be responsible for supporting innovative packaging and accessory designs to comply with industry and Cryoport standards. This position will work closely with our quality department to ensure the designs are well documented and maintain a design history file throughout its life cycle. The Packaging & Design Engineer also works collaboratively with the Product Management and Product Marketing teams to ensure the company’s products are developed to meet and exceed end user needs and are built to address real market challenges. This role is client-facing to support Consulting Services by driving client engagement and delivering offerings related to packaging and accessory design and development. The position spans both Cryoport Consulting Services and Cryoport Bioservices, while also collaborating closely with Cryoport Engineering on innovative new projects. This is a hybrid role between Packaging and Design teams. Most of the time will be engaged in Packaging designs and when needed to engage with the Design Engineering team.

  • Following a user centered design process
  • Primary and Secondary Packaging Products, Accessories for temperature controlled products
  • Prototyping and manufacturing packaging designs used in temperature-controlled supply chain solutions for life sciences
  • Rapidly develop client and Cryoport solutions using industry standard software tools like ArtiosCAD, Inventor, SolidWorks, etc.
  • A solid understanding of Thermodynamics (Thermal transfer and heat transfer) with a focus on ultra-cold temperatures
  • Product Development
  • Packaging Engineering
  • Sustaining Engineering/Product Lifecycle management
  • Manufacturing Engineering
  • Engineering Documentation
  • Estimating and gathering quotes
  • Drive to ensure all product elements are executed to scope, budget, and time
  • Verification, Validation and Test Plan Development
  • Manage and adhere to the Engineering Change Order and Change Control process
  • Provide engineering leadership to broader engineering team and junior colleagues
  • All packaging, labeling and accessories must function across the intended temperature ranges required by our clients (and supported by Cryoport)
  • Packaging must be designed for multiple types of shipping systems (and temperature ranges) and can include boxes/cartons, inserts, bags, racking, cassettes/canisters/vials, customized immobilization elements, development of custom kits for Bioservices, etc.
  • Experience with labeling, label testing and labeling challenges across the cold chain (all the way to cryogenic temperatures) is highly valued and desired
  • All packaging and accessory development should meet the requirements of ISO 21973 Biotechnology – General requirements for transportation of cells for therapeutic use
  • Assessing market requirements per project, based on sales and marketing requirements, which will include customer input for specific projects
  • Participate in a User Centered Design Process, including communicating with a variety of teams and stakeholders
  • Participate in these projects once they have been approved
  • Assist with creating budgets, timescales and specifications with PD Project Management, clients and managers to meet sales and marketing goals
  • Liaising with suppliers for optimum relationships and results
  • Problem solving
  • Undertaking relevant research for advancing the company objectives
  • Research new materials and methods of development
  • Producing and implementing designs and test procedures
  • Measuring performance of mechanical components, devices, and processes
  • Testing, evaluating, modifying, and re-testing products
  • Creating good documentation of designs, writing engineering reports and concise operating / assembly procedures
  • Providing technical advice within industry standards and regulations
  • Analyzing and interpreting data
  • Field engineering
  • Client education, by working in conjunction with Product Marketing, Marketing and Product Management
  • Designing new products ensures components and assemblies adhere to applicable industry and business standards and manufacturability
  • Sustaining existing products with engineering support and design modifications
  • B.S./B.A. in Packaging /Design Engineering or related field; M.S or higher preferred
  • 2+ years experience in materials engineering, industrial design, DFM/DFA/DFMEA/PFMEA
  • Solid modeling using ArtiosCAD and SolidWorks, or equivalent parametric modeling software (Autodesk Inventor)
  • Manufacturing engineering including manufacturing and assembly process development and documentation, Lean six sigma background preferred
  • Experience in Thermal simulations using Inventor and SolidWorks
  • Strong knowledge and hands on experience with polymers, glass, metal, flexible paperboard & corrugated packaging material and manufacturing process, printing and decorating technologies, injection molding, thermoforming Roto Molding, and blow molding
  • Experience working closely with contract manufacturing, prototyping, and packaging manufacturing
  • Understanding and expertise in cold chain/temperature sensitive logistics and supply chain
  • Experience designing packaging for performance and protection of core payload
  • Experience designing core payload holders which performs under industry standard shipper qualifications
  • Experience directly performing, overseeing and/or collaborating on physical, thermal and shipping qualification of packaging
  • Knowledge and experience with relevant standards and guidelines including but not limited to: ISTA, ASTM, CFR, ISO, PDA, WHO, GxP, etc.
  • Experience building and/or collaborating on validation protocols, executing protocols and building reports for shipping system validation/qualification and testing following industry standards
  • Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM)/ Design for Assembly (DFA) tools and methods are desirable
  • Understanding and/or direct experience with cGMP and FDA validation methodology is desirable
  • MS Office with proficiency in Excel and Access – ability to capture, analyze, and present complex experimental and product design data
  • Strong CAD design experience with Artios CAD, SolidWorks, Autodesk Inventor or equivalent
  • Knowledge and understanding of international Physical and Thermal Performance testing standards, including, but not limited to ISTA, IATA, ISO, and ASTM regulations as it relates to packaging distribution and thermal testing and associated requirements
  • A good understanding of Thermo Dynamics
  • Packaging design including electronics
  • Heat transfer experience
  • Understanding and experience in Cold Chain and temperature-sensitive logistics
  • Packaging testing and qualification
  • Shipper testing and qualification
  • Good Distribution Practices (GDP)
  • USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products
  • 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Pharmaceutical products
  • 21CFR Part 211 cGMP for Finished Pharmaceuticals
  • Demonstrated analytics ability using large volumes of data in excel and creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics
  • Ability to distill complex data analysis into protocols, reports, and presentations to clients
  • Technical knowledge of packaging equipment like form-fill-seal, shrink tunnel, labeler, conveyer systems, etc.
  • Experience in developing Validation Activities (supporting Bio-Pharmaceuticals – Cell and Gene Therapies) – with a focus around supply chain, logistics, shipping systems, and packaging
  • Project Management skills/training
  • Self-starter - an individual who can start or undertake a project on his or her own initiative, without needing to be told or encouraged to do so
  • A collaborative team player who embraces and champions innovation to enhance Cryoport’s culture, with internal and external teams
  • Compensation: Up to $140,000 depending on experience + bonus + stock
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