Traceability-Event Operating Architecture Director — Medical-Device Distribution

The mandate

These are durable, serialised devices that move through hospital loan pools and service returns, not one-way cartons whose trace ends at delivery. A unit may be commissioned, packed into a kit, disaggregated, issued on loan, cleaned, repaired, returned and quarantined across different 3PL and hospital systems. Partners publish EPCIS 2.0 events, but they disagree on serial identity, parent-child aggregation, custody, condition and correction. A syntactically valid event cannot prove which physical device is usable or bound a recall population.

The deliverable is an outsourced Device-Event Control Architecture defining which partner must publish, verify, correct and retain each commissioning, aggregation, shipment, receipt, loan, return, service, condition and quarantine event. It specifies loan start and close evidence, serial-to-kit genealogy, condition assertions, physical verification, late-event clocks, recall use and manual fallback. EPCIS is the exchange grammar; Quality disposition, device release and physical custody remain separate authorised decisions.

The opening month proves twelve serial-level device journeys—including loan issue, hospital use, return and quarantine—and records every event gap. Quality, recall and outsourced-partner constraints are locked by week nine. The week-fourteen milestone defines decision-grade events; ten partner controls follow at week twenty and recall playbooks at week twenty-five. Four physical trials run through week thirty-four, leaving two weeks to accept the architecture and prioritised backlog.

Acceptance requires client and partner teams to resolve unseen aggregation break, serial duplication, sensor-gap, late shipping event, hospital return and recall expansion while preserving custody and Quality authority. The Supply Chain Officer and Quality Vice President sign only when operators can challenge event truth, bound affected devices and use a tested manual fallback without consultant queries.

The client will provide EPCIS samples, identifiers, partner contracts, device journeys, sensor and certification records, recall cases, Quality rules, physical access and empowered owners. Exclusions include repository or API build, device release, recall decision, regulatory filing, partner selection, sensor qualification, live inventory movement and assurance of technical conformance to the standard.

Why this is external work

Technology teams can validate an EPCIS message and Quality can disposition a known device, but neither controls how twelve outsourced partners record a hospital loan, kit break, service return or condition change. A generic traceability blueprint would miss that serial-level operating problem. The independent director must make partner events answerable to physical device and loan evidence without becoming repository developer, Quality approver or regulatory adviser.

What you will own

• Trace twelve device journeys across commissioning, packing, aggregation, shipping, receipt, loan, return and quarantine.
• Define operational meaning, publisher, timing, evidence, correction and decision use for critical EPCIS events.
• Design partner controls for serial duplication, late events, aggregation breaks, sensor gaps and unknown locations.
• Link event evidence to custody, condition, recall population, customer communication and accountable Quality decision.
• Establish manual capture and reconciliation when partner repositories, identifiers or connectivity fail.
• Rehearse serial conflict, missing sensor data, delayed receipt, hospital return and expanding recall scope.
• Deliver the architecture, event dictionary, partner controls, recall playbooks, trials and an accepted implementation backlog ordered by patient consequence, partner evidence gaps and validation dependency.

Candidate qualifications

• Led serialised medical-device distribution or traceability operations across multiple outsourced logistics partners.
• Operationalised EPCIS 2.0 or equivalent visibility events beyond repository and interface implementation.
• Reconciled aggregation, custody, condition and serial evidence through repack, loan, return and quarantine.
• Supported recall population decisions while preserving accountable Quality and regulatory authority.
• Designed partner and manual fallbacks for late, missing, duplicated or semantically weak events.
• Transferred traceability architecture through physical client-led trials and an expanding recall scenario involving aggregation breaks, condition evidence and disputed partner custody.

Non-negotiables

• Can lead ten partner laboratories and four Brussels-governed trials within nine months.
• Direct regulated traceability operating experience is required; data-platform engineering alone is insufficient.
• Will disclose manufacturers, 3PLs, hospitals, standards firms, platforms and sensor vendors.
• Will not release devices, decide recalls, qualify sensors, file regulations or build repositories.

1. 49 words maximum. Describe a valid visibility event that failed to represent physical device custody.
2. 49 words maximum. How would you bound recall population after an aggregation break?
3. 49 words maximum. Which partner event and physical records must be available by week two?