Chemical Engineer – MedTech Oncology Embolics

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

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.