Sustaining Engineer

Cryoport, Inc.•Irvine, CA

21h

About The Position

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. Summary The Sustaining Engineer is responsible for the ongoing support, maintenance, and continuous improvement of Cryoport ís existing products, systems, and accessories. This role ensures products remain reliable, manufacturable, compliant, and aligned with customer and operational needs throughout their lifecycle. The position works closely with Quality, Operations, Supply Chain, and Product Management to resolve issues, implement improvements, and maintain robust engineering documentation and change control. Role: As a Sustaining Engineer, you will focus on maintaining and improving released products and processes, including: • Supporting day-to-day engineering needs for existing products and accessories • Leading root cause investigations, participate in the Material Review Board (NCM, CAPAís, etc.), and implementing corrective actions • Driving product and process improvements for quality, cost, and reliability • Managing engineering changes through ECO and Change Control processes • Supporting design, manufacturing, assembly, field (at the manufacturer, LC) issue resolution, and assist in process improvements • Maintaining and updating engineering documentation and specifications • Ensuring compliance with internal standards and applicable regulations • Collaborating cross-functionally to sustain product performance and supply continuity

Requirements

Product development engineering experience
Strong problem-solving and analytical skills
Experience with root cause analysis and structured problem-solving methods
Knowledge of change control and configuration management
Solid understanding of manufacturing processes and product lifecycle support
Ability to manage multiple priorities in a fast-paced environment
Strong communication and cross-functional collaboration skills
Detail-oriented with a focus on quality and compliance
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related field
2-10+ years of experience in sustaining engineering, manufacturing engineering, or product support
Experience supporting released products in production and field environments
Thermal dynamics knowledge and experience is highly recommended
Strong background in engineering change management (ECO/ECR)
Strong experience with CAD tools (e.g., SolidWorks, Inventor)
Familiarity with DFM/DFA and manufacturing processes (e.g., molding, fabrication, assembly)
Experience working in regulated industries is a plus
Proficiency in Microsoft Office (especially Excel)
Experience with CAD (Solidworks, Inventor or the like) and PLM/document management systems
Familiarity with data analysis and reporting tools
Ownership mindset with a focus on product reliability and performance
Proactive, hands-on problem solver
Strong collaborator across functions and teams
High level of integrity, accountability, and attention to detail
Continuous improvement mindset

Nice To Haves

Experience in cold chain, cryogenic systems, or temperature-controlled packaging
Familiarity with relevant standards (ISTA, ASTM, ISO, IATA)
Working knowledge of cGMP and regulated environments
Experience with Six Sigma, Lean, or similar continuous improvement tools
Data analysis skills (Excel, statistical tools)
Experience supporting contract manufacturers and global supply chains

Responsibilities

Consult with the primary engineering owner for released products to understand the design intent
Troubleshoot product, manufacturing, and field issues and implement solutions
Lead root cause analysis (RCA) and corrective/preventive actions (CAPA)
Initiate and execute engineering changes (ECOs) as required for design changes and follow existing product development processes in the concept, design, testing and implementation of product improvements
Update drawings, BOMs, specifications, and assist with work instructions updates where needed
Support suppliers and contract manufacturers as well as working alongside the quality department to resolve quality or supply issues
Identify and implement cost reduction and product optimization opportunities (including, but not limited to, leveraging off the shelf solutions first in determining product optimization solutions)
Monitor product performance and drive continuous improvement initiatives (and collaborate with Product Management)
Support validation, verification, and testing as needed for changes
Ensure proper documentation and adherence to quality systems (e.g., cGMP, ISO)
Provide technical support to internal teams (Operations, Quality, Commercial, Marketing)
Assist with revalidation activities as required
Communicate with cross functional teams of projectís status
Ensure that project learnings are integrated into future design plannings and executions