Chemical Engineer

Siemens Healthineers in; Austin (TX); On-site; USD 95,000 - 140,000; Full time

Job summary

Siemens Healthineers is seeking a Chemical Engineer to join the IO embolics development team. You will develop new implantable therapy and embolization products, and maintain existing microsphere products, contributing to life-changing cancer treatments.

The role emphasizes design, regulatory knowledge, and collaboration across R&D and manufacturing to drive continuous improvements and ensure FDA/QSR/ISO‑13485 compliance.

Qualifications

• Chemical Engineer with interest in medical device development.
• Experience aligning design with regulatory standards.
• Familiarity with FDA DHF and ISO 13485 guidance.

Responsibilities

• Develop and define microsphere formulations and synthesis methods.
• Develop prototype intravascular devices to demonstrate feasibility.
• Understand and design thermal spray processes.
• Incorporate homogenization for batch consistency.
• Operate high temperature furnaces and analyze data.
• Transfer synthesis processes to manufacturing for production.
• Plan and execute complex test plans with data interpretation.
• Create design and fabrication plans and instrumentation drawings.
• Plan R&D activities for implantable devices.
• Perform quality assurance testing to meet design specs.
• Write technical documentation and test methods.
• Maintain FDA Design History Files (DHF) and regulatory compliance.
• Contribute to process improvements under FDA 510(k), QSR, ISO 13485.
• Participate in investigations and failure analyses.

Skills

Biomedical device development

Self-driven

Quality system compliance

FDA 510(k) familiarity

Design History Files (DHF)

Job description

Chemical Engineer (Finance)

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Siemens Healthineers is looking for a Chemical Engineer to join our interventional oncology (IO) development team. The individual will be a member of our growing embolics team that is focused on treating cancers by delivery internal chemical/radiation therapy and occluding the blood supply to tumors. The individual would contribute by developing new implantable therapy and embolization products, new applications for existing microspheres, and maintaining our existing microsphere 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 changes people's lives.

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