Material Scientist

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Siemens Healthineers is seeking a Materials Scientist to join our Interventional Oncology (IO) development team.

The individual will be a member of our growing embolization product development team that is focused on treating cancers by delivering internal chemical/radiation therapy and occluding the blood supply to tumors.

The individual would contribute by leading the materials research and testing aspects of design and development related to new implantable therapy and embolization products.

The ideal candidate would be a self-driven individual with a passion for medical device development and a desire to work on products that change people's lives.

Responsibilities


* Support design and development of novel chemical and materials-based devices, including chemical (XRD, DSC, leachable, etc), radiation-related, and mechanical (stiffness, sizing, etc) assessments


* Provide material science expertise in glass, ceramic, and polymer-based medical devices


* Lead coordination with external chemical test laboratories to evaluate devices


* Development and execution of complex chemical and mechanical verification protocols involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements


* Validate analytical and mechanical test methods for design verification and process development


* Create verification reports based on test results


* Contribute to and maintain FDA compliant Design History Files (DHF)



* Execute test processes as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485


* Participate in complaint investigations, and failure analysis of products


* Provide root cause analysis support and drive the implementation of corrective action for process-related issues


* Performs other duties as assigned or required

Qualifications & Experience


* BS in Chemical Engineering, Biomedical Engineering, or related filed; MS or PhD preferred


* 3+ years of materials science and testing experience with preference to assessment of medical devices


* Experience in chemical, radiation, and mechanical testing and test method validation of material-based products and devices is preferred


* Experience managing external testing vendor relationships and requirements



* Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry


* Experience in the development of regulatedmedical devicesor combination products is preferred


* Experience with de...