Medical Device Safety Review Engineer
Class
84702a8f
http://proethica.org/ontology/intermediate#MedicalDeviceSafetyReviewEngineer
Definition
A licensed professional engineering role in which an engineer employed by a medical device or equipment manufacturer is asked by a colleague to evaluate a product for safety concerns, identifies a potentially life-threatening design defect, escalates findings internally to management, and — when the employer fails to act — bears an obligation to report the hazard to an appropriate federal regulatory agency to protect vulnerable end-users (e.g., infants, patients) from serious harm.
Properties
Subclass of
Definition
A licensed professional engineering role in which an engineer employed by a medical device or equipment manufacturer is asked by a colleague to evaluate a product for safety concerns, identifies a potentially life-threatening design defect, escalates findings internally to management, and — when the employer fails to act — bears an obligation to report the hazard to an appropriate federal regulatory agency to protect vulnerable end-users (e.g., infants, patients) from serious harm.
Source Evidence
Source Text
Engineer B asks Engineer A to evaluate a respirator designed by MedTech for infant use
TTL
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix proethica_intermediate_extended: <http://proethica.org/ontology/intermediate-extended> .
<http://proethica.org/ontology/intermediate#MedicalDeviceSafetyReviewEngineer> a owl:Class ;
rdfs:label "Medical Device Safety Review Engineer" ;
rdfs:comment "A licensed professional engineering role in which an engineer employed by a medical device or equipment manufacturer is asked by a colleague to evaluate a product for safety concerns, identifies a potentially life-threatening design defect, escalates findings internally to management, and — when the employer fails to act — bears an obligation to report the hazard to an appropriate federal regulatory agency to protect vulnerable end-users (e.g., infants, patients) from serious harm." ;
rdfs:subClassOf <http://proethica.org/ontology/intermediate#EmployerRelationshipRole> .
Metadata
Ontology
Type
Class
Content Hash
84702a8fe6a921ac...Last Updated
2026-03-12 16:49
Extraction Provenance
Discovered in Case
150
Discovered In Pass
1
Discovered In Section
facts
First Discovered At
2026-02-28T14:29:19.696851+00:00
First Discovered In Case
150
Generated
2026-02-28T14:29:19.696851+00:00
Was Attributed To
Case 150 Extraction