Responsibilities
* Architects 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.
Qualifications
* Bachelor degree in engineering or similar
* Min 4 years of experience in
* Proven experience with global submissions, preferably including FDA,
* Excellent communication and problem-solving skills.
* Fluent in English (written and spoken)
* Office based