Packaging & Design Engineer

Cryoport Systems is the life science industry's most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24 / 7 / 365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

POSITION SUMMARY

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.

PRIMARY RESPONSIBILITIES (include but are not limited to) :

• 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

COMPETENCIES & PERSONAL ATTRIBUTES :

QUALIFICATIONS AND EDUCATION REQUIREMENTS :

Education

Experience 2+ years experience in the following disciplines :

o Cold Chain and temperature-sensitive logistics

o Packaging testing and qualification

o Shipper testing and qualification

o (GDP) Good Distribution Practices

o USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products

o 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Pharmaceutical products

o 21CFR Part 211 cGMP for Finished Pharmaceuticals

Compensation : Up to $140,000 depending on experience + bonus + stock