Senior Design & Manufacturing Engineer

Cryoport Systems; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

An established industry player in the life sciences sector is seeking a Senior Design & Manufacturing Engineer to join their innovative team. This role is crucial in supporting the development of cutting-edge solutions for temperature-sensitive materials. You'll engage in user-centered design processes and collaborate with cross-functional teams to ensure compliance with industry standards. With a focus on innovative packaging designs and risk reduction in cold-chain logistics, this position offers a unique opportunity to impact the future of regenerative medicine and biopharmaceuticals. If you're passionate about engineering and eager to contribute to meaningful advancements, this is the perfect role for you.

Benefits

401K with company match

Stock options

Equity

Excellent benefits

Qualifications

• 10+ years in materials engineering and manufacturing.
• Experience with ISTA, ASTM, CFR, ISO standards.

Responsibilities

• Design temperature-controlled products and packaging.
• Develop prototypes and manufacturing designs.
• Ensure compliance with industry standards.

Skills

Problem-solving skills

Math and statistics

Data analysis

Project management

Attention to detail

Education

BS in Mechanical Engineering

Tools

Autodesk Inventor

SolidWorks

MS Office

Job description

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Company Overview: Cryoport Systems is a trusted provider in the life sciences industry, specializing in supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF, surrogacy, and animal health organizations worldwide. Our proprietary Cryoport Express shippers, Cryoportal Logistics Management Platform, Smartpak Condition Monitoring System, and geo-sensing technology, combined with logistics expertise and 24/7 support, make us the end-to-end temperature-controlled supply chain partner you can rely on.

Job Title:

Senior Design & Manufacturing Engineer

Type:

On-site

Location:

Irvine, California, USA

Travel Requirement:

15%

Position Summary:

The Senior Design & Manufacturing Engineer plays a vital role on the New Product Development Team, supporting life science and regenerative medicine clients through all phases of clinical and commercial development. The role focuses on understanding, quantifying, and reducing cold-chain, logistics, and packaging risks, supporting innovative packaging designs in compliance with industry standards and Cryoport standards. The engineer will collaborate closely with quality, product management, and marketing teams to ensure products meet market needs and standards.

Primary Responsibilities:

• Follow user-centered design processes
• Design temperature-controlled products, accessories, and packaging (including cryogenic solutions)
• Develop prototypes and manufacturing designs for supply chain solutions
• Utilize industry software such as ArtiosCAD, Inventor, SolidWorks for rapid development
• Apply thermodynamics knowledge, focusing on ultra-cold temperatures
• Engage in new product development, sustaining engineering, and product lifecycle management
• Prepare engineering documentation, estimates, and quotes
• Ensure developments adhere to scope, budget, and schedule
• Develop verification, validation, and test plans
• Manage engineering change processes
• Provide leadership within the engineering team
• Assess market and customer requirements
• Conduct user-centered design activities involving multiple stakeholders
• Develop budgets, timelines, and specifications
• Liaise with suppliers to optimize relationships
• Perform problem-solving and research to improve company offerings
• Create and implement design and test procedures
• Measure and evaluate product performance
• Document designs, write reports, and develop procedures
• Provide technical advice compliant with standards and regulations
• Analyze data and perform field engineering as needed
• Educate clients in conjunction with marketing teams
• Design new products ensuring compliance and manufacturability
• Sustain existing products through engineering support and modifications

Competencies:

• Problem-solving skills with a focus on budget, cost, and timelines
• Proficiency in math, statistics, data analysis, and software tools
• Hands-on experience with polymers, metals, glass, and packaging manufacturing processes
• Knowledge of packaging equipment and technical communication skills
• Attention to detail, analytical thinking, and project management abilities
• Self-motivated with strong organizational skills

Preferred Skills:

• Knowledge of international testing standards (ISTA, ISO, ASTM, etc.)
• Experience in electronics packaging, heat transfer, and cold chain logistics
• Understanding of regulatory requirements (GxP, CFR, USP, 21CFR)
• Data analytics and project management training

Qualifications & Education:

BS or higher in Mechanical Engineering

Experience:

Minimum 10+ years in materials engineering, industrial design, manufacturing, thermal simulations, and cold chain logistics. Experience with standards such as ISTA, ASTM, CFR, ISO, and validation protocols is preferred.

Technology Skills:

Proficiency in MS Office, CAD software (Autodesk Inventor, SolidWorks), and data analysis tools.

Personal Attributes:

• Alignment with Cryoport’s mission
• Collaborative, innovative, and ethical mindset
• Strong communication, organizational, and analytical skills
• Results-driven with a continuous learning attitude

Salary:

Up to $160,000, commensurate with experience. Cryoport offers excellent benefits, 401K with company match, stock options, and equity.