Process Engineer (Sustainability/Product Lifecycle)
Cryoport · Irvine · $130,000 (stated in the posting)
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
• 3-6 years of experience in sustaining engineering, manufacturing engineering, process engineering, or product lifecycle 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
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