For Medical-Device Manufacturing Engineers
Medical-device Manufacturing Engineer — build the process, not the binder.
You own the work instructions and the process.
Operators work from an out-of-date paper copy.
Work instructions are controlled documents with revisions, shown with the production steps.
Readings are hand-written and hard to check.
Record readings at the step.
Labels get mixed up at the end of the line.
Where label printing is configured, print lot labels from V5 as part of the work.
All problems V5 helps with5 in total
Operators work from an out-of-date paper copy.
Work instructions are controlled documents with revisions, shown with the production steps.
Readings are hand-written and hard to check.
Record readings at the step. Automatic capture from scales and other devices requires a supported, configured connection.
Labels get mixed up at the end of the line.
Where label printing is configured, print lot labels from V5 as part of the work.
Equipment status is hard to check before use.
Equipment and maintenance records, including calibration due dates, are kept in V5.
Finding the cause of yield loss means digging through paper.
Recorded production steps, lots and signatures give you structured data to review.
A day as a Medical-Device Manufacturing Engineer with V5
Review yesterday's production records and OEE, check which equipment is due for calibration or maintenance, then open a work order to see the current instruction, the operator and the readings recorded so far.
Checks to run in your evaluation5 checks
- Which readings must be captured at each step, and which could come from connected devices?
- Which devices are in use, and are they supported by V5's configured connections?
- How will a new instruction revision reach the floor under your change procedure?
- What does your device history record need to contain for each lot or unit?
- V5 supports your own procedures and validation. The software does not by itself establish compliance, certification or a validated state.
Modules you will useShop Floor Execution, eDHR, Scheduling & Dispatch, Inventory & Warehouse
Shop Floor Execution
Work orders run as controlled production steps on the kiosk.
eDHR
Device history records built from recorded steps.
Scheduling & Dispatch
Schedule board, capacity and shift planning.
Inventory & Warehouse
Lots, picking and traceability.
Maintenance & OEE
Equipment, maintenance and calibration due dates.
Document control
Controlled work instructions with revisions and signing.
Common questions3 answers
- Which devices does V5 connect to?
- Automatic measurements need a supported, configured connection. Tell us which devices you use and we'll confirm what is supported.
- Can we run V5 on the line without disrupting ERP?
- V5 is designed to work alongside an existing ERP. ERP connections need their own configuration.
- Do operators need to learn a new screen?
- Yes, the V5 kiosk replaces the paper traveller. Expect some adjustment; starting with one line helps.