Post-Acquisition Operations Integration Architecture Director — Medical Devices

The mandate

The acquired surgical-instruments company runs make-to-stock planning, local supplier qualification and depot-level repair release, while the buyer uses procedure-linked demand, global category controls and central service authorisation. Integration teams have catalogued systems but not the operating decisions connecting lot release, shortage allocation, complaint escalation and repaired-device return. Premature standardisation could interrupt hospital supply or compromise regulated evidence.

The defined deliverable is an Operations Integration Architecture containing decision rights, process and control differences, target-state choices, transitional states, dependency maps, cutover waves, readiness measures and exception governance across manufacturing, supply, quality and service. It must identify which acquired practices should remain, which buyer standards are mandatory and where an interim bridge is safer than forced harmonisation.

Milestone one at week four accepts the product-flow and decision inventory; week eight closes regulatory and quality constraints. Target choices are approved by week thirteen, transitional controls by week seventeen, and eight site plans by week twenty-two. Two integrated rehearsals and one abort test conclude by week twenty-seven; final accepted architecture and implementation backlog land at week thirty.

Acceptance requires site owners to execute twelve unseen decisions involving shortage, supplier deviation, complaint-linked stock and repair release using approved authority and traceable evidence. Quality and the Integration Executive sign only after the client team rehearses a failed cutover, returns safely to the transitional state and demonstrates that no release record, hospital allocation or complaint handoff depends on consultant memory.

The client will provide transaction assumptions, regulatory commitments, product and site inventories, quality-system maps, supplier records, planning data, service flows, complaint interfaces, technology constraints and empowered workstream owners. Excluded services are live batch or device release, regulatory filing, supplier selection, ERP configuration, workforce restructuring, legal advice, implementation command and synergy assurance beyond the agreed operations architecture.

Why this is external work

Both legacy organisations defend practices that have kept their own products compliant, and the integration office lacks specialist capacity to test them at decision level. An independent architecture can distinguish justified regulatory difference from inherited habit without becoming the operator, quality approver or advocate for either legacy company.

What you will own

• Map product, information and authority flows from supplier approval through manufacturing, release, distribution, complaint and repair.
• Compare legacy decisions for control purpose, regulatory evidence, cycle time, service consequence and local dependency.
• Define target, transitional and retained operating states with explicit entry, exit, fallback and accountable-owner conditions.
• Sequence site cutovers around validation, inventory, hospital continuity, supplier readiness and complaint-system dependencies.
• Build readiness measures that expose missing evidence rather than rewarding nominal process or system completion.
• Rehearse shortage allocation, supplier deviation, complaint quarantine, repair release, cutover failure and controlled rollback.
• Deliver the integration blueprint, decision matrix, control bridges, wave plans, acceptance pack and implementation backlog.

Candidate qualifications

• Architected regulated operations integrations following medical-device, diagnostics or comparable life-sciences acquisitions.
• Reconciled quality-system, service and supply decisions without treating system migration as proof of operating integration.
• Designed transitional controls, cutover gates and rollback states around traceable regulated records and customer continuity.
• Understood manufacturing release, complaints, field service, supplier qualification and hospital allocation interfaces.
• Challenged buyer and acquired-company assumptions while preserving accountable Quality and regulatory decision rights.
• Transferred a complete integration architecture through client-led adverse scenarios and a deliberately aborted cutover.

Non-negotiables

• Can lead eight site laboratories and all three Minneapolis-governed cutover rehearsals within seven months.
• Direct regulated operations integration is required; generic post-merger programme management is insufficient.
• Will disclose device manufacturers, integration advisers, contract manufacturers, distributors and quality-system vendors.
• Will not release product, file regulatory changes, select suppliers, configure ERP, restructure teams or guarantee synergies.

1. 49 words maximum. Describe an acquired operating practice you retained because buyer standardisation created greater regulated risk.
2. 49 words maximum. How did you prove a transitional control could survive a failed cutover?
3. 49 words maximum. Which complaint-to-inventory scenario would you require before architecture acceptance?