Sustaining Engineer

Cryoport Systems, LLC; Irvine (CA); On-site; USD 117,000 - 143,000; Full time

Benefits offered by this job

Bonus

Stock options

Benefits package

Job summary

Cryoport Systems, LLC located in Irvine, California is searching for a Sustaining Engineer responsible for maintenance and improvement of existing products and systems. This role emphasizes collaboration with cross-functional teams to ensure product reliability and compliance.

Qualifications include a Bachelor’s in Mechanical Engineering and 2–10+ years of relevant experience. The compensation package includes a salary up to $130,000, alongside bonuses and benefits.

Qualifications

• 2–10+ years of experience in sustaining engineering or product support.
• Experience with engineering change management (ECO/ECR).
• Familiarity with regulated industries is a plus.

Responsibilities

• Support day-to-day engineering needs for existing products.
• Lead root cause investigations and implement corrective actions.
• Drive product and process improvements for quality and reliability.

Skills

Problem-solving

Product development engineering

Analytical skills

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering

Tools

Microsoft Office (Excel)

CAD software (SolidWorks, Inventor)

Job description

Summary

The Sustaining Engineer is responsible for the ongoing support, maintenance, and continuous improvement of Cryoport’s existing products, systems, and accessories. This role ensures products remain reliable, manufacturable, compliant, and aligned with customer and operational needs throughout their lifecycle.

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, participating in the Material Review Board (NCM, CAPA, 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 issue resolution, and assisting 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
• Update drawings, BOMs, specifications, and assist with work instruction updates where needed
• Support suppliers and contract manufacturers and work alongside the quality department to resolve quality or supply issues
• Identify and implement cost reduction and product optimization opportunities, including leveraging off‑the‑shelf solutions
• Monitor product performance and drive continuous improvement initiatives, collaborating 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 about project status
• Ensure that project learnings are integrated into future design planning and execution

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: 2–10+ years in sustaining engineering, manufacturing engineering, or product support; experience supporting released products in production and field environments; thermal dynamics knowledge recommended; strong background in engineering change management (ECO/ECR); strong experience with CAD tools; familiarity with DFM/DFA and manufacturing processes (e.g., molding, fabrication, assembly); experience 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; 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, plus bonus, stock, and benefits.