Medical-device Manufacturing Engineer — build the process, not the binder.
You own the routing, the work instructions, the fixture spec, the torque profile, the vision recipe and the label. Your job is to build a process that yields a compliant device every single time — and today, half your day is spent making sure the paper batch record matches what the floor actually did. V5 replaces the paper: the routing is locked to the released DMR revision, calibrated tools push readings live, the UDI label prints at the workstation, and the eDHR self-builds per serial as the operator works.
The 5 problems we hear from every Medical-Device Manufacturing Engineer.
Operators see stale work instructions because the paper copy in the binder hasn't been swapped.
The kiosk pulls the current released DMR revision at every step. There is no paper copy to be out of date, and an operator cannot open the old revision after cutover.
Torque, vision and inspection readings are hand-keyed and drift from what the tool actually captured.
Calibrated torque drivers, vision cameras, scales and dimensional gauges push readings directly to the eDHR. Out-of-spec triggers a hold at the step; the tool cannot be used past its calibration due date.
UDI labels are printed at the end of the line and mis-matched to serials.
The DI + PI label prints at the workstation at the moment the serial is committed to the DHR. The reprint audit trail is intact and searchable.
Every DMR change means re-writing the traveller and re-training operators, and the two are always out of sync.
A DMR revision drives a routing revision, a document-control revision and a training re-issue in one workflow. Operators cannot start on the new revision until training is signed for that revision.
Root cause on yield loss takes weeks because the data is on paper.
Structured step-level data — cycle time, torque reading, vision result, operator, tool serial, calibration status — is live in V5. Yield variance by shift / line / operator / DMR revision surfaces same-shift, not month-end.
What changes Monday morning.
Stand-up at 7:30 — pull the overnight OEE per cell, yesterday's yield by DMR revision, any tools that hit calibration due today, any DHR held for out-of-spec. Walk the floor with the handheld; tap any workstation to see the current DMR revision, the operator, the current step and the last torque or vision reading. Push a new work-instruction revision at 10:00 — training re-issues to the affected operators, and the next serial on that station starts on the new revision.
What the numbers look like.
| Metric | Before | With V5 |
|---|---|---|
| Work-instruction cutover time | Days (print + swap + re-train) | Same day, gated at kiosk |
| Torque / vision transcription errors | Ambient in paper records | Zero — pushed live from calibrated tools |
| Yield-loss root-cause turnaround | 1–3 weeks | Same shift — step-level data live |
| UDI mis-label rate | Occasional line stops | Zero — label prints at commit |
The modules that matter for your role.
Shop floor execution
Kiosk-led routing — DMR-locked, gloves-friendly, scanner + scale + torque integrated.
eDHR
Per-serial device history — built live as the operator works, locked at final inspection.
Scheduling & dispatch
Route work by cell and skill, react to reality without re-writing paper.
Inventory & warehouse
Kitting, lot / serial traceability, bin-to-workstation, ship.
Maintenance & OEE
Calibration due dates that gate tool use, structured downtime, PMs tied to assets.
Document control
Work instructions and DMR documents versioned, signed, training-bound.
Questions Medical-Device Manufacturing Engineers ask us.
Which calibrated tools does V5 integrate with?+
Torque (Atlas Copco, Cleco, Kolver, Ingersoll Rand, Stanley), vision (Cognex, Keyence, Zebra), scales (Mettler Toledo, Sartorius, Ohaus), dimensional gauges (Marposs, Renishaw) and generic OPC-UA / MQTT for anything else. Calibration due dates gate tool use at the step; an expired tool cannot record a signed reading.
Can we run V5 on the line without disrupting ERP?+
Yes — V5 sits between ERP and the floor. Work orders come from ERP, V5 executes them against the locked DMR revision, lot / serial consumption posts back. Customers run V5 alongside SAP, Oracle, NetSuite, Dynamics, Epicor and Infor.
Do operators need to learn a new UI on top of the current one?+
No — the V5 kiosk replaces the paper traveller and the barcode scanner UI, it doesn't add to them. First two shifts are a small productivity dip; by week two operators are faster than paper because they aren't chasing signatures or flipping pages.
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