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. Job title: Senior Design & Manufacturing Engineer Type: On-site Location: Irvine, California USA Travel requirement: 15% POSITION SUMMARY The Senior Design & Manufacturing Engineer plays an integral role on the New Product Development Team, which assists life science and regenerative medicine clients across all phases of clinical and commercial development with a spectrum of offerings aimed at understanding, quantifying and reducing cold-chain supply chain, logistics and/or packaging risks. The Senior Design & Manufacturing Engineer will be responsible for supporting innovative packaging and accessory designs to comply with industry and Cryoport standards. This position will work closely with our quality department to ensure the designs are well documented and maintain a design history file throughout its life cycle. The Senior Design & Manufacturing Engineers also works collaboratively with the Product Management and Product Marketing teams to ensure the company's products are developed to meet and exceed end user needs and are built to address real market challenges PRIMARY ROLE As a Senior Design & Manufacturing Engineer at Cryoport Systems, you will be responsible for a wide variety of tasks / roles including, but not limited to, the following: * Following a user-centered design process * Primary and Secondary Temperature-Controlled Product (including Cryogenic), Accessory and Packaging designs * Prototyping and manufacturing designs used in temperature-controlled supply chain solutions for life sciences * Rapidly developing client and Cryoport solutions using industry standard software tools like ArtiosCAD, Inventor, Solidworks, etc. * A solid understanding of Thermodynamics (Thermal transfer and heat transfer) with a focus on ultra-cold temperatures * New Product Development * Sustaining Engineering/Product Lifecycle management * Manufacturing Engineering * Engineering Documentation * Estimating and gathering quotes * Drive to ensure all developments are executed to scope, budget and time * Verification, Validation and Test Plan Development * Managing and adhering to the Engineering Change Order and Change Control process * Provide engineering leadership to broader engineering team and junior colleagues * Assess market requirements per project, based on sales and marketing requirements, which will include customer input for specific projects * Conduct a User Centered Design Process, including a variety of teams and stake holders * Pursue these projects once they have been approved * Develop budgets, timescales and specifications with NPD Project Management, clients and managers to meet sales and marketing goals * Liaise with suppliers for optimum relationships and results * Problem solving * Undertake relevant research for advancing the company * Research new materials and methods of development * Producing and implementing designs & test procedures * Measuring performance of mechanical components, devices, and processes * Testing, evaluating, modifying, and re-testing products * Creating good documentation of designs, writing engineering reports and concise operating / assembly procedures * Providing technical advice within industry standards and regulations * Analyzing and interpreting data * Field engineering * Client education, by working in conjunction with Product Marketing, Marketing and Product Management * Designing new products to ensure components and assemblies adhere to applicable industry and business standards and manufacturability * Sustaining existing products with engineering support and design modifications COMPETENCIES * Ability to problem solve and find creative solutions to complex Cryoport and client packaging and shipper engineering problems - on budget, to meet target cost/price and on time * Proficient math, statistics and data analysis skills including a familiarity with Microsoft Office applications and other data analysis and modeling tools * Strong knowledge and hands-on experience with polymers, glass, metal, flexible paperboard & corrugated packaging material and manufacturing process, printing and decorating technologies, injection molding, thermoforming Roto Molding, and blow molding. * Technical knowledge of packaging equipment like form-fill-seal, shrink tunnel, labeler, conveyer systems, etc. * Strong communications skills and ability to communicate complicated packaging considerations and designs to clients and internal stakeholders in a clear, meaningful, and concise manner * Demonstrates strong attention to detail and analytical thinking * Ability to manage multiple projects within overlapping timeframes * Self-starter - an individual who can start or undertake a project on his or her own initiative without needing to be told or encouraged to do so PREFERRED SKILLS * Knowledge and understanding of international Physical and Thermal Performance testing standards, including, but not limited to ISTA, IATA, ISO, and ASTM regulations, as it relates to packaging distribution and thermal testing and associated requirements * Packaging design including electronics * Heat transfer experience * Understanding and experience in: * Cold Chain and temperature-sensitive logistics * Packaging testing and qualification * Shipper testing and qualification * (GDP) Good Distribution Practices * USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products * 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Pharmaceutical products * 21CFR Part 211 cGMP for Finished Pharmaceuticals * Demonstrated analytics ability using large volumes of data in excel and creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics * Ability to distill complex data analysis into protocols, reports, and presentations to clients * Project Management skills/ training QUALIFICATIONS AND EDUCATION REQUIREMENTS Education: BS or higher in Mechanical Engineering Experience 10+ years' experience in the following disciplines: * Materials engineering, industrial design, DFM/DFA/DFMEA/PFMEA * Solid modeling using Autodesk Inventor or equivalent parametric modeling software (Solidworks). * Manufacturing engineering including manufacturing and assembly process development and documentation, Lean Six Sigma background preferred * Experience in Thermal simulations using Inventor and Solidworks * Experience working closely with contract manufacturing, prototyping, and packaging manufacturing * Understanding and expertise in cold chain/temperature sensitive logistics and supply chain * Experience designing packaging for performance and protection of core payload * Experience designing core payload holders which performs under industry standard shipper qualifications * Experience directly performing, overseeing and/or collaborating on physical, thermal and shipping qualification of packaging * Knowledge and experience with relevant standards and guidelines including but not imited to: ISTA (thermal and performance testing standards), ASTM (physical performance testing standards), CFR, ISO, PDA, WHO, GxP, etc. * Experience building and/or collaborating on validation protocols, executing protocols and building reports for shipping system validation/qualification and testing following industry standards * Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM)/ Design for Assembly (DFA) tools and methods are desirable * Understanding and/or direct experience with cGMP and FDA validation methodology is desirable Technology Skills * MS Office with proficiency in Excel and Access - ability to capture, analyze, and present complex experimental and product design data * Strong CAD design experience with Autodesk Inventor, Solidworks or equivalent PERSONAL ATTRIBUTES * Passion for and alignment with Cryoport's mission. * Team player, a change agent and strong collaborator who is not afraid of challenging the status quo. * An individual who brings strong core values, quality, ethics, and integrity and a continuous learning attitude to improve personal competencies, understanding and capabilities * A collaborative team player who embraces and champions innovation and Cryoport's culture * Strong work ethic and ability to deliver results and meet commitments in a dynamic environment * Communications skills with the ability to clearly communicate and document * Organizational and planning skills, strong analytical abilities, and process orientation * Demonstrates a business process orientation to engineering and has ability to formulate projects and, after approved, take them to finality Salary: Up to $160,000 commensurate with experience Cryoport offers exceptional benefits, 401K with company match and stock equity