Senior Design & Process Engineer-USA

• 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.

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 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.

Qualifications:

Education:

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