Sustaining Engineer

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

Job summary

Cryoport, Inc. is looking for a Sustaining Engineer in Irvine, California to support and improve existing products and processes. The role involves collaborating with cross-functional teams, leading root cause investigations, and ensuring compliance with quality systems.

The ideal candidate will possess a Bachelor's degree in Mechanical Engineering and 2-10+ years' experience in sustaining engineering. Experience with CAD tools and strong analytical skills are essential. Compensation is competitive, with base salary up to $130,000 plus bonuses and benefits.

Qualifications

• 2-10+ years of experience in sustaining engineering or product support.
• Experience with engineering change management.
• Strong background in CAD tools.

Responsibilities

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

Skills

Problem-solving skills

Analytical skills

Communication skills

Detail-oriented

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Excel

Job description

## Sustaining EngineerApplylocations: Irvine, Californiatime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR101565Cryoport 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 SmartpakTM 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**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** • 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**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 toolsPersonal 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