Note: The job is a remote job and is open to candidates in USA. Siemens Healthineers is a healthcare technology company developing solutions to improve patient outcomes. The Chemical Engineer will support the interventional oncology development team by creating implantable therapy and embolization products, developing microsphere formulations and synthesis methods, and contributing to testing, quality assurance, documentation, and regulated medical device production.
Responsibilities
- Develop and define glass, ceramic, and polymer microsphere formulations and synthesis methods to meet device needs
- Develop prototype intravascular devices to demonstrate technical feasibility
- Understand, operate, and design various thermal spray processes
- Incorporate homogenization for consistency of batches
- Utilization of high temperature furnaces
- Interpretation of material characterization data
- Transfer knowledge of synthesis processes to manufacturing for ongoing production
- Development and execution of complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements
- Contribute to formal design and instrumentation drawings, analysis plans, and fabrication plans
- Plan and conduct R&D activities to define and develop implantable devices
- Quality assurance testing of devices to ensure conformance to design specifications
- Write technical documentation including process descriptions and test methods
- Contribute to and maintain FDA compliant Design History Files (DHF)
- Execute process improvements 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
Skills
- BS in Chemical Engineering, Ceramics/Materials Engineering, Biomedical Engineering, or related field
- 1+ years of engineering experience with preference to experience in medical device or other regulated industry
- Knowledge of glass, ceramic, and polymer materials engineering, production, and formulation
- Able to define and develop test procedures and to perform design verification
- Knowledge of laboratory techniques for analyzing microsphere properties and chemical composition is preferred
- Experience working within a company's Quality System is preferred
- Experience in the development of regulated medical devices or combination products is preferred
Benefits
- Commission eligibility in accordance with the terms of the Company's plan, based on individual performance and/or company performance
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- Life insurance
- Long-term and short-term disability insurance
- Paid parking/public transportation
- Paid time off
- Paid sick and safe time
Company Overview
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