Sustaining Engineer

Sustaining 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.

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

• 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

• 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

• 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

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

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