ResponsibilitiesArchitects and executes the creation of medical device solutions by converting abstract clinical concepts into precise technical requirements and engineering blueprints.Curates specialized materials, manufacturing workflows, and external partners to fulfill design objectives, while auditing these designs against performance criteria, clinical environments, and international regulations.Directs the fabrication of experimental components for engineering assessments, pre-clinical research, and human clinical trials, while serving as a primary technical decision-maker.Engineers scalable production workflows by identifying critical process variables through statistical methodologies like DOE, encompassing the acquisition of new equipment, tooling design, and supplier negotiation.QualificationsBachelor degree in engineering or similarMin 4 years of experience inProven experience with global submissions, preferably including FDA,Excellent communication and problem-solving skills.Fluent in English (written and spoken)Office based