Manufacturing Transfer Readiness Engineer (ID #547137)

Job Title: Manufacturing Transfer Readiness Engineer

Address

San Clemente, California

Employment Type

Not specified

Pay

$42.00 per hour

JOB PURPOSE:

The Manufacturing Transfer Readiness Engineer is a hands-on technical role assigned to prepare medical-device manufacturing processes, equipment, tooling, records, data, and operating knowledge for transfer to another

location. The role observes actual manufacturing and supporting processes, compares current practice with controlled documentation, develops missing technical content, inspects transfer assets, and drives closure of

readiness gaps. The position creates an accurate and reproducible transfer package so the receiving site can install, qualify, validate, train, and operate the transferred processes with minimal ambiguity and controlled product,

quality, safety, and service risk.

PRIMARY RESPONSIBILITIES:

• Observe manufacturing and supporting operations at the sending site, including medical tubing extrusion and applicable secondary, inspection, packaging, material-handling, maintenance, calibration, quality, and data recording

activities. Document the actual sequence, process inputs and outputs, setup methods, ranges and fixed settings, adjustment logic, equipment/tooling used, acceptance criteria, troubleshooting methods, and critical operator decisions.

• Create and maintain a complete machine and ancillary-equipment inventory. For each asset, document identification, manufacturer/model/serial number, current use, location, condition, transfer disposition, utilities,

interfaces, controls/software, safety features, special installation needs, and available technical records.

• Review and organize equipment technical files, including preventive and corrective maintenance history, Installation Qualification records, operating and service manuals, calibration requirements and status, recommended spare parts, special tools, supplier/service contacts, and known reliability or obsolescence

concerns. Identify missing or inadequate records and coordinate closure.

• Inspect equipment and support functional testing before disconnection or shipment. Define or support documented acceptance criteria, pre-move condition evidence, photographs, configuration records, and functional checks needed to demonstrate that assets are complete and operating as intended before transfer.
• Create a complete tooling, fixture, gauge, pin, die, screw, mandrel, guide, cutter, winder, and change-part inventory. Record asset identification, associated products/processes, storage location, condition, quantity, material, critical dimensions, calibration or verification needs, and transfer disposition.
• Develop or coordinate missing tooling drawings, schematics, specifications, photographs, and dimensional records. Verify that tooling matches its applicable drawing or create objective baseline evidence where no controlled drawing currently exists.
• Audit process documentation against actual practice by observing experienced operators and technicians. Correct ambiguity and capture setup details, process windows, adjustment methods, visual standards, photographs/screenshots, electronic data-collection steps, scrap/rework criteria, inspection points, and

troubleshooting guidance required for repeatability at the receiving site.

• Capture undocumented "tribal knowledge" through structured interviews, direct observation, video or photographic evidence where permitted, and witnessed execution of processes. Convert knowledge into controlled work instructions, setup guides, troubleshooting guides, training content, and transfer notes.
• Review the transfer scope for Device Master Record content and supporting manufacturing records, including BOMs, routings, process specifications, work instructions, drawings, material/component specifications, inspection procedures, test methods, labels, forms, validation records, PFMEAs, control plans, and applicable Design History File references. Create a reconciliation list and close or escalate missing, inaccurate, or obsolete content.
• Define validation and requalification needs for transferred equipment, tooling, processes, utilities, inspection methods, and test equipment. Support transfer validation planning and readiness for IQ/OQ/PQ, test-method validation, comparative/functional testing, pilot builds, and documented acceptance at the receiving site.
• Inventory and prepare manufacturing data for transfer or migration, including IQMS or other manufacturing system master data, item records, BOMs, routings, specifications, recipes, parameter sheets, electronic records, manual forms, historical process data, inspection data, calibration data, maintenance records, and traceability requirements. Reconcile source data to controlled documents and identify ownership for migration and verification.
• Review inspection and functional-testing requirements across incoming, in-process, final, pre-shipment, receiving, installation, and post-installation stages. Confirm required instruments, gauges, fixtures, sample plans, methods, acceptance criteria, calibration, measurement-system suitability, and objective evidence.
• Develop training needs, curricula, qualification criteria, training materials, trainer assignments, and knowledge transfer plans for receiving-site operators, technicians, maintenance personnel, inspectors, and engineers.

Coordinate hands-on demonstrations and verify that training records and evidence are complete.

• Perform process-readiness assessments covering process flow, capability, yield, PFMEA, CAPA/nonconformance history, current controls, equipment, utilities, tooling, documentation, training, and data. Record each gap, risk, action, owner, due date, closure evidence, and residual risk.
• Apply the approved remediation strategy to each gap, such as fix before move, fix during move, or fix after move before validation/closure. Drive action completion, verify objective evidence, and escalate threats to

transfer timing, product quality, safety, compliance, cost, or continuity of supply.

• Coordinate daily with Operations, Manufacturing Engineering, Quality, Maintenance, Metrology, Validation, IT, Supply Chain, Document Control, EHS, vendors, and receiving-site representatives. Provide concise status

reports, readiness metrics, risk updates, decisions required, and a controlled handoff of final deliverables.

• Support asset preservation, labeling, packaging, disconnection, shipment, receiving verification, installation, and post-installation issue resolution as assigned. Confirm that transferred assets, records, spare parts, tooling,

and documentation match the approved inventory and disposition plan.

• Complete a final sending-site transfer-readiness dossier and handoff package, including reconciled asset inventories, document index, open-item register, gap-closure evidence, training package, validation inputs, data migration

evidence, inspection/test requirements, photographs, and lessons learned.

REQUIRED DELIVERABLES:

• Approved equipment and ancillary-equipment master inventory with condition, documentation, utilities, spare parts, calibration, maintenance, transfer disposition, and functional-test status.
• Approved tooling/fixture/gauge inventory with condition assessment and controlled drawings, specifications, photographs, or dimensional baseline evidence.
• Current-state process maps and observed-practice assessments for manufacturing and support processes, with gaps against controlled documentation.
• DMR/manufacturing-document reconciliation matrix and completed or assigned remediation actions. • Manufacturing-data migration inventory and reconciliation covering IQMS/system records, BOMs, routings, recipes, specifications, forms, and historical records.
• Validation, qualification, inspection, functional-testing, and receiving-acceptance requirements for equipment, tooling, processes, utilities, and test methods.
• Tribal-knowledge and troubleshooting package, supported by photographs, screenshots, demonstrations, and controlled instructions where appropriate.
• Training plan, materials, qualification criteria, attendance/qualification evidence, and receiving-site knowledge transfer record.
• Risk and gap register with disposition strategy, owner, due date, status, objective closure evidence, and residual risk/escalation status.
• Final sending-site readiness and handoff dossier supporting shipment, installation, qualification, validation, and project closure.

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

• Bachelor's degree in Mechanical, Manufacturing, Chemical, Biomedical, Plastics, Industrial, or related engineering discipline; equivalent relevant technical education and extensive hands-on experience may be considered.
• Typically 5+ years of manufacturing, process, equipment, validation, or transfer engineering experience in a regulated manufacturing environment; medical-device manufacturing experience strongly preferred.
• Demonstrated ability to observe a process, distinguish actual practice from written procedure, identify technical and documentation gaps, and convert shop-floor knowledge into clear, reproducible instructions.
• Hands-on experience with manufacturing equipment, tooling, fixtures, gauges, maintenance records, calibration, equipment qualification, technical manuals, spare parts, and functional testing.
• Working knowledge of medical-device quality systems and transfer documentation, including ISO 13485, FDA QMSR/21 CFR Part 820, DMR/DHF concepts, document/change control, traceability, nonconformance/CAPA,

risk management, and validation IQ/OQ/PQ.

• Experience with polymer processing or medical tubing extrusion and secondary operations is strongly preferred. Familiarity with extrusion heads, pins/dies, screws, cooling, pullers, cutting, winding, bonding, printing, forming, inspection, and cleanroom practices is advantageous.
• Ability to read and create technical drawings and specifications; CAD/SolidWorks capability preferred. Competence with dimensional inspection, measurement systems, process capability, DOE, PFMEA, control

plans, and statistical software is preferred.

• Experience with ERP/MES/QMS data and manufacturing master-data migration; IQMS experience is preferred. Strong Microsoft Excel, Word, PowerPoint, and structured data-management skills are required.
• Strong technical writing, interviewing, photography/documentation, organization, and configuration-control skills. Able to manage a high volume of assets and records without loss of traceability.
• Able to work independently at the sending site, build credibility with experienced operators and technicians, challenge incomplete information constructively, and drive closure across functions without direct authority.
• Available for frequent manufacturing-floor presence, potential travel between sending and receiving sites as required, and work around production schedules, equipment shutdowns, shipment windows, and validation activities.

SUCCESS MEASURES:

• All in-scope equipment, tooling, documents, data, training content, and transfer records are inventoried, traceable, and dispositioned.
• Observed manufacturing practice is accurately documented and reproducible without dependence on unwritten assumptions.
• Readiness gaps have an approved strategy, accountable owner, required completion evidence, and timely escalation of unresolved risk.
• Assets arrive with the records, tooling, spare parts, configuration information, and acceptance evidence required for installation and qualification.
• The receiving-site team has the documentation, training, inspection methods, validation inputs, and operating knowledge needed to execute the transfer plan.

WORKING CONDITIONS:

Work is performed in office, manufacturing, cleanroom, and equipment areas. The employee regularly sits, stands, walks, communicates, and uses computers, hand tools, and measurement equipment; may occasionally bend, kneel, climb stairs, work near moving equipment or moderate noise, and lift or move items up to 50 lb. Travel and work outside normal hours may be required to support launches, transfers, customers, suppliers, or urgent production needs. Reasonable accommodations may be made to enable qualified individuals to perform essential functions. Site-specific requirements govern where they differ.

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