Senior Design

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.

Summary:

The Senior Design and Process Engineer is a hybrid role that plays an integral role on the 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 and Process Engineer will be responsible for supporting innovative designs by adopting processing methods that comply with industry and Cryoport standards. This position will work closely with our quality and logistic operation department to ensure the processes have been developed ane are well documented. When required the Design and Process Engineer will participate in developing innovative designs. The Senior Design and Process Engineer also works collaboratively with the Product Management and Product Marketing initiatives to ensure the company's products are adequately processed so they can meet and exceed end user needs.

Role:

Mostly this position will report to the Manager for Process Engineering but where required will also work with the Manager for Design Engineering.

As a Senior Design and Process Engineer at Cryoport Systems you will be responsible for a wide variety of tasks / roles including but not limited to the following:

• Develop and optimize production processes to improve efficiency, quality, and cost-effectiveness,
• Following a user centered design process,
• Rapidly develop client and Cryoport solutions using industry standard software tools like AutoCAD, Autodesk Vault and Inventor, Solidworks, etc.,
• New Process, Tooling, Equipment Development,
• Sustaining Engineering/Process Lifecycle management,
• Manufacturing Engineering,
• Sequence of Events
• Engineering Documentation,
• Estimating and gathering quotes,
• Drive to ensure all product elements are executed to scope, budget, and time,
• Verification, Validation and Test Plan Development,
• Manage and adhere to the Engineering Change Order and Change Control process,
• Provide engineering leadership to broader engineering team and junior colleagues.

• Responsible for conducting a User Centered Design Process, including a variety of teams and stake holders.
• Pursuing these projects once they have been approved.
• Developing timescales and specifications with PD Project Management, clients and managers to meet sales and marketing goals.
• Liaising with suppliers for optimum relationships and results.
• Problem solving.
• Undertaking relevant research for advancing the company

• Research new methods of process manufacturing.
• Producing and implementing process designs and testing procedures.
• Measuring process performance.
• Testing, evaluating, modifying, and re-testing processes.
• Creating good documentation of processes, writing engineering reports, protocol, reports, and concise operating / assembly procedures.
• Analyzing and interpreting data.
• Field engineering as required.
• Developing new processes that ensures components and assemblies adhere to applicable industry and business standards and manufacturability while ensuring a safe environment.
• Sustaining existing processes with engineering support and design modifications.
• Perform assessments of inputs and outputs to meet process and/or process specifications
• Modifying released documentation using existing quality-controlled processes.
• Develop cutting edge fixtures, tooling, and equipment.
• Manage builds for new product process development in a pilot or production setting.
• Developing/modifying Sequence of Events.
• Troubleshoot assembly issues.
• May develop and conduct statistical analysis or recommend additions to process documents
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
• Collaborates with product development teams to support new product development by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
• Perform other duties as needed.

• 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 familiarity with Microsoft Office applications and other data analysis and modeling tools.
• Familiarity with manufacturing technologies, including injection molding, thermoforming Roto Molding, and blow molding.
• Strong communications skills.
• Demonstrates strong attention to detail and analytical thinking.
• Ability to manage multiple projects within overlapping timeframes.
• Team player, a change agent and strong collaborator who is not afraid of challenging the status quo.
• 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.
• A collaborative team player who embraces and champions innovation to enhance Cryoport's culture, with internal and external teams.
• Strong work ethic, core values and ability to deliver results and meet commitments in a dynamic environment understanding quality and integrity.
• Must be able to lift, push, pull and carry up to 25 lbs.
• Familiarity with Primary and Secondary Temperature Controlled (including Cryogenic) Product, Accessory and Packaging designs.
• Familiarity with Thermodynamics (Thermal transfer and heat transfer) with a focus on ultra-cold temperatures.
• Familiar with industry standards and regulations.

• Familiarity with 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.
• Familiarity with 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 and Time Management skills.
• Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary.
• Value Stream Mapping and other lean methodology principals.

• Minimum Requirements: Bachelor's degree ideally in Manufacturing or Mechanical Engineering

• 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.
• Familiarity in Thermal simulations using Inventor and Solidworks.
• Experience working closely with contract manufacturing, prototyping, and packaging manufacturing.
• Understanding in cold chain/temperature sensitive logistics and supply chain.
• 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 limited 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 process 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.
• Experience with manufacturing line layout, capacity analysis, and line balancing.
• Experience with design and process FMECA, process validation, and process control.
• Knowledge of six sigma, 5S, design for manufacturability, and lean methodologies.

• Understanding and/or direct experience with cGMP and FDA validation methodology is desirable.
• Knowledge of Engineering Change Order process.

• 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.
• Strong experience with data management software used to organize, manage, and track design and engineering documentation.

• 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.