Engineering Capabilities
From Design Files to Production
R&D design, NPI, test development, automation, and reliability testing — built for medical device programs where traceability and design validation are regulatory requirements.
R&D Design Services
Our team covers the full design spectrum — initial concept through to the documentation package needed to start production.
Electronic Engineering
Schematic capture, PCB layout, signal integrity analysis, power delivery design. Particular depth in mixed-signal and low-noise front-end design for medical monitoring and diagnostic devices.
Mechanical Engineering
Enclosure design, thermal management, tolerance analysis, assembly design. For devices where IP rating, ergonomics, or drop performance are regulatory requirements, ME is part of the process from day one.
Firmware Development
Embedded firmware for medical device control boards — communication protocols, sensor interfaces, power management, OTA update mechanisms. Familiar with software lifecycle documentation requirements.
Industrial Design
Product form, UI layout, visual language. ID decisions for clinical devices affect both usability and regulatory assessment — our ID team works alongside ME and EE from the concept stage.
Prototyping & 3D Modelling
Rapid prototyping for form and fit verification, 3D modelling for mechanical design validation, sample builds for early functional testing before committing to production tooling.
Product Reliability Testing
Design validation testing — environmental, mechanical, and electrical stress testing against intended use conditions — before design freeze. Full capabilities in the Reliability section below.
New Product Introduction(NPI)
29 engineers managing the transition from design files to stable production across four stages.
Pre-stage
Test Solution
Implementation
Qualification
Test Development
Functional and in-circuit test capabilities designed, built, and maintained in-house.
Functional Circuit Test (FCT)
Customer-specified or jointly developed functional test procedures, implemented in custom fixtures built in-house. Covers signal outputs, communication interfaces, power consumption, sensor readings, and any other parameters that define whether the board performs its intended function.
In-Circuit Test (ICT)
Bed-of-nails or flying-probe ICT for component-level verification — presence, orientation, and value — before functional testing begins.
Automated LED Checking
Automated verification of colour, brightness, and sequence for boards with status indicators. No operator visual inspection on this step.
Automated Button & Switch Actuation
Automated actuation mechanisms integrated into the test fixture for consistent actuation force and contact across every unit.
MES Integration & Data Traceability
All test results captured through MES and linked to board serial number. The test record — pass/fail, measured values, date/time, operator ID, test station ID — is part of the production record for each specific unit, available for DHR documentation.
Automation Solutions
In-house automation engineering team using our own machining equipment — engraving, milling, grinding, CNC lathe.
Pneumatic Fixtures
Custom pneumatic clamping and actuation fixtures for boards and assemblies where precise, repeatable positioning is required — connector pin-to-pad alignment, component seating force control.
Semi-Automatic Assembly
Automated screw driving, adhesive dispensing, contact film application. Reduces operator variability without the volume requirement of full automation.
Robotic Assembly Cells
Pick-and-place robotic cells on EPSON platforms for component assembly, board handling, and sub-assembly integration — built and programmed in-house for specific product configurations.
Automated Testing & Packing Lines
End-of-line automation covering functional testing, visual inspection, label application, and packing. MES data capture at each station maintains traceability through the full sequence.
Reliability & Failure Analysis
Testing labs at both Dongguan and Bac Ninh facilities — same people who built the board investigate any failures.
Failure Analysis
- Cross-section analysis — via barrel integrity, solder joint quality, delamination
- Chemical de-capsulation of ICs for die-level failure analysis
- IV curve tracing against known-good references
- Metalloscopic inspection to 1,000× magnification
- Thermal imaging under operating conditions
- Strain gauge measurement for assembly and use-condition stress
- X-ray fluorescence spectrometry for material composition verification
Environmental Testing
- Salt spray — corrosion resistance
- Constant temperature and humidity chambers
- Temperature and humidity cycling
- Rapid temperature change — thermal shock
- Drip-proof testing for IP rating verification
- Hot-and-cold impact chambers
- Xenon lamp UV weathering resistance
Mechanical Testing
- Three-coordinate geometry metrology
- X-Rite spectrophotometric surface measurement
- Surface hardness, torque, and rupture strength
- Button and toggle switch life cycle testing
- Automatic plug-and-pull force — connectors
- Wire bending and flex life testing
Package Testing
- Vibration testing
- Mechanical shock testing
- Drop testing — board-level and packaged product
- Compression testing
Injection Moulding & Tooling
Enclosure and component manufacturing managed under the same ISO 13485 quality system as PCB assembly.
| ×5 CNC machining centres | ×7 EDM machines |
| ×4 Wire-cut machines | ×8 Milling machines |
| 0.003mm Steel tolerance | 15000 Max RPM |
| 42+ Injection moulding machines | 60–1,300t Clamping force range |
| 3,300g Max product weight | 135×80cm Max product size |
Capabilities: standard injection, double-shot, vertical, insert moulding, PMMA/optical lens moulding.
The Earlier Engineering Gets Involved, the Better
Most engineering problems that surface during production could have been addressed in DFM review, NPI, or test development — if those conversations happened earlier.
Request a DFM Review
Upload your Gerber files and BOM. DFM analysis runs through Mentor Valor — prioritised report returned within 24 hours. No commitment required.
Discuss NPI Requirements
Share your timeline, regulatory requirements, and test specification status. We'll outline the NPI process for your specific program and flag any lead-time considerations early.
Talk to an Engineer
Stack-up questions, test strategy, reliability concerns, or anything else — our engineers are available for a direct conversation.