Sustaining Engineer

Vereinigte Staaten

Irvine, California, Vereinigte Staaten

Über die Stelle

Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.

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

Key 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

Core Competencies

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

Preferred Skills

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

Qualifications

Education
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or

related field Experience

5-10+ 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

Technology Skills

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

Personal Attributes

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

Compensation: up to $130,000 depending on experience + bonus + stock + benefits

Sprachen

Sustaining Engineer

Über die Stelle

Role

products and processes, including

Key Responsibilities

Core Competencies

Preferred Skills

Qualifications

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