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Mechanical Engineering

Bringing physical systems to life through design, build, test, and commercialization
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Core Offerings

  • Mechanical design for durable instruments and devices, as well as consumables and disposable devices
  • Systems architecture and integration 
  • Analysis and modeling: fluidic, thermal, optical, structural, and motion 
  • Compliance with safety standards and regulations 
  • Prototyping and rapid iteration 
  • Testing and validation 
2295 KeyTech S06 2081
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Applying practical science to address challenging needs 

At Key Tech, our Mechanical Engineering department is built on a passion for the physical sciences and a curiosity to understand new technologies. Our team excels in supporting applications involving diagnostic chemistry, advanced optics, precision motion systems, and fluidic control. Leveraging our collective experience and first principles approaches, we tackle the most challenging problems and develop robust, innovative solutions tailored for in vitro diagnostics, medtech, pharma, and bioprocess industries. 

We design for success 

Through a combination of holistic systems thinking, user-centric design approaches, and data-driven decision making, we balance the needs of all stakeholders throughout the product lifecycle. Our process begins with technology feasibility and usability assessments, followed by derisking testing to validate concepts and product architectures. During design implementation, we focus on functionality, cost, manufacturing, assembly, testing, service, and sustainability. The result is successful products that meet functional requirements, comply with regulatory standards, and delight users. 

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Mechanical Engineering Solutions

ME MechDesignDev

  • CAD Modeling and Drafting 
  • Design for manufacturability (DFM) 
  • Design for assembly (DFA) 
  • Prototype development 
  • Rapid prototyping 
  • 3D printing 
  • Injection molding 
  • Sheet metal design 
  • Structural design 
  • Ergonomic design 
  • Material selection
  • Design optimization 
  • Finite element analysis (FEA) 
  • Computational fluid dynamics (CFD) 
  • Thermal management 

ME SystemsArch

  • Systems engineering 
  • Integration of mechanical and electrical systems 
  • Mechatronics 
  • Sensor integration 
  • Actuator design 
  • Control systems 
  • Automation solutions 
  • Fluid handlers 
  • Fluidic cartridges/ consumables 
  • Robotics integration 
  • Data acquisition systems 
  • Custom algorithm development 
  • Mechanical system testing 
  • Multidisciplinary collaboration 
  • Prototype integration 
  • System optimization
  • Performance analysis 

ME AnalysisModeling

  • Fluid dynamics analysis 
  • Thermal analysis 
  • Optical analysis 
  • Structural analysis 
  • Motion analysis 
  • Vibration analysis 
  • Stress analysis 
  • Fatigue analysis 
  • Dynamic simulation 
  • Multiphysics simulation 
  • Heat transfer analysis 
  • Flow simulation 
  • Acoustic analysis 
  • Electromagnetic analysis 
  • Reliability analysis 
  • Uncertainty analysis, tolerance stack-up, and error budget 

ME Prototyping

  • Rapid prototyping 
  • Functional prototyping 
  • Proof-of-concept testing 
  • Usability testing 
  • Performance testing 
  • Environmental testing 
  • Reliability testing 
  • Accelerated life testing 
  • Failure mode and effects analysis (FMEA) 
  • Design verification testing (DVT) 
  • Support for compliance and validation testing 
  • Custom test fixtures 
  • Test automation 
  • Data analysis and reporting 

ME MfgFab

  • Design for manufacturability (DFM) 
  • Design for assembly (DFA) 
  • Prototype assembly and testing 
  • Pilot run assembly 
  • Consumable manufacturing 
  • CNC machining 
  • Additive manufacturing (3D Printing) 
  • Injection molding 
  • Casting and forging 
  • Sheet metal fabrication 
  • Welding and joining 
  • Surface treatment and coating 
  • Custom fabrication solutions 
  • Collaboration with contract manufacturers (CMs) 
  • Design transfer to commercial production 

ME RegulatoryCompliance

  • FDA compliance 
  • ISO, IEC, and safety standards (e.g. IEC 61010, IEC 60601, ISO 11608) 
  • CE marking 
  • UL certification 
  • RoHS compliance 
  • REACH compliance 
  • GMP (Good Manufacturing Practices) 
  • Risk management 
  • Environmental regulations 
  • Documentation and reporting 
  • Compliance testing 

ME InnovResearch

  • Technology feasibility studies 
  • Concept development 
  • Early-phase R&D 
  • Proof-of-concept experiments 
  • Sensitivity analysis 
  • Characterization of new technologies 
  • Workflow assessment for devices and users 
  • Risk assessment and mitigation 
  • Prototype testing and iteration 
  • Experimental design and execution 
  • Data collection and analysis 
  • User feedback integration 
  • Design optimization
  • Performance evaluation 
  • De-risking new technology 

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Download Key Techs Capabilities Overview