Design & Manufacturing 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.

Job title: Design & Manufacturing Engineer

Type: On-site

Location: Irvine, California USA

Travel requirement: 15%

POSITION SUMMARY
The Design & Manufacturing Engineer will play an integral role on the Product Development Team, assisting 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 Design & Manufacturing 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 Design & Manufacturing 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.
 
PRIMARY ROLE
As a Design & Manufacturing Engineer at Cryoport Systems, you will be responsible for a wide variety of tasks / roles including, but not limited to, the following:

• Following a user-centered design process
• Primary and Secondary Temperature-Controlled Product (including Cryogenic), Accessory and Packaging designs
• Prototyping and manufacturing designs used in temperature-controlled supply chain solutions for life sciences
• Rapidly developing 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
• Sustaining Engineering/Product Lifecycle management
• Manufacturing Engineering
• Engineering Documentation
• Estimating and gathering quotes
• Ensuring all product elements are executed to scope, budget, and time
• Verification, Validation and Test Plan Development
• Managing and adhering to the Engineering Change Order and Change Control process
• Providing engineering leadership to broader engineering team and junior colleagues
• 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
• Undertaking relevant research for advancing the company objectives
• Researching new materials and methods of development
• Producing and implementing designs & 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 to ensure components and assemblies adhere to applicable industry and business standards and manufacturability
• Sustaining existing products with engineering support and design modifications
   

COMPETENCIES

• Ability to problem solve and find creative solutions to complex Cryoport and client packaging and shipper engineering problems – on budget, to meet target cost/price and on time
• Proficient math, statistics and data analysis skills i