Engineer III - R & D Engineering (Medical Devices

Position Summary - Engineer III (R & D Engineering)

The Engineer III leads the design, development, verification, and sustaining engineering of vascular access devices and their associated manufacturing processes. Working under limited supervision, the Engineer III independently plans and executes complex engineering projects — including device and fixture design, test method development, process and equipment qualification, and technical investigations — and owns the associated documentation in compliance with the Quality Management System and applicable regulatory requirements.

The role exercises sound engineering judgment on ambiguous or novel technical problems, provides technical guidance to less experienced engineers and technicians, and leads cross‑functional design and process review activities. The Engineer III maintains a patient‑first mindset throughout the design process, engaging directly with physicians and other clinical stakeholders to translate real‑world clinical needs into clear, robust product specifications that support safe and effective device performance.

The duties below are representative of the work performed in this role. They are not intended to be an exhaustive list.

• Lead device and component design, development, and testing activities, including protocol authoring, test execution, data analysis, and technical report preparation in accordance with design control procedures.
• Own and maintain Design History File (DHF) and Device Master Record (DMR) content for assigned projects; review contributions from junior engineers for completeness and accuracy.
• Design, model (Solid Works), and fabricate test and manufacturing fixtures, including CAD modeling and additive manufacturing (3D printing) of prototypes and tooling.
• Lead or actively participate in design and process reviews, presenting technical rationale and risk/benefit analysis to cross‑functional stakeholders.
• Develop, author, and maintain product specifications — including design inputs, design outputs, and engineering drawings — that accurately translate physician and clinical end‑user needs into clear, testable engineering requirements.
• Participate in physician interactions, including voice‑of‑customer sessions, product evaluations, and cadaver or bench labs, incorporating clinical feedback into device design with patient safety and usability as the top priority.

• Plan, design, and execute test method validations (TMV), measurement systems analysis (MSA) including Gage R&R studies, and designs of experiments (DOE); interpret results and recommend engineering action.
• Lead equipment qualification activities including IQ — authoring protocols and reports, executing testing, and resolving deviations.
• Develop statistical rationale for sampling plans, sample sizes, acceptance criteria, and confidence/reliability targets, and review rationale developed by others.

• Lead or contribute significantly to risk management activities including DFMEA and use‑related FMEA (uFMEA); author and maintain risk management file content in accordance with ISO 14971, ensuring patient safety and clinical risk are systematically identified, evaluated, and mitigated throughout the device lifecycle.
• Lead design characterization, specification development, and test method development activities.
• Author, assess, and approve engineering change orders (ECOs) and change control records, including impact and testing assessments.
• Lead technical investigations for nonconformances, CAPAs, and complaint investigations. Complaint reportability and regulatory decisions remain the responsibility of Quality Assurance and Regulatory Affairs.

• Fabricate prototypes, fixtures, and tooling using filament‑based (FDM) and resin‑based (SLA/DLP) 3D printers, including print setup, material selection, and post‑processing.
• Use basic hand and shop tools — including a band saw, belt sander, drill press, and similar equipment — to fabricate, cut, and finish prototypes and test fixtures.
• Follow all applicable safety…