Cryoport Systems · 4 months ago
Packaging & Design Engineer
Irvine, California
Full-time
Hybrid
Entry, Mid Level
$0/yr - $140K/yr
2+ years expCryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials. The Packaging & Design Engineer will play a crucial role in supporting innovative packaging designs that comply with industry standards while collaborating with various teams to meet client needs and address market challenges.
Clinical TrialsLogisticsShipping
Responsibilities
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 stake holders
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
Qualification
Required
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
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 (thermal and performance testing standards), ASTM (physical performance testing standards), 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
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
Preferred
M.S or higher in Packaging /Design Engineering or related field
Lean six sigma background
Experience in Thermal simulations using Inventor and SolidWorks
Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM)/ Design for Assembly (DFA) tools and methods
Understanding and/or direct experience with cGMP and FDA validation methodology
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
(GDP) Good Distribution Practices
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
Benefits
Bonus
Stock
Company
Cryoport Systems
Cryoport Systems is a market leader in globally integrated temperature-controlled supply chain support for critical, irreplaceable products and materials in the Life Sciences industry.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.11BKey Investors
Blackstone Group
2021-11-10Post Ipo Debt· $350M
2021-01-19Post Ipo Equity· $287.5M
2020-08-25Post Ipo Equity· $275M
Leadership Team
J
Jerrell W. Shelton
Chief Executive Officer
Robert S. Stefanovich
SVP, CFO and Treasurer
Recent News
BioTech Breakthrough
2025-11-08
BioTech Breakthrough
2025-11-07
Company data provided by crunchbase