Manufacturing Readiness Transfer Engineer

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.

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.

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.

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.

Qualifications and requirements:

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.