R&D Lab Technician – Implantable Medical Devices

Siemens Healthineers in; Austin (TX); On-site; USD 66,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Paid time off

Job summary

Siemens Healthineers seeks an R&D Lab Technician to join our Interventional Oncology team in Austin, Texas. The role focuses on testing, analysis, and development of embolics devices, with emphasis on process development and DHF documentation.

Ideal candidates hold an associate or 4-year degree in biology/chemistry/physics and 2+ years in a regulated lab, with familiarity of FDA QSR/ISO 13485 preferred. Join us to help deliver breakthrough healthcare solutions in a diverse, global environment.

Qualifications

• 2+ years of laboratory experience with preference for medical device or regulated industry
• Knowledge of lab techniques such as microscopy, FTIR, HPLC and microsphere analysis methods is preferred
• Experience with regulatory issues (FDA QSR/ISO 13485) is a plus
• Experience in development of regulated medical devices or combination products is preferred

Responsibilities

• Apply basic scientific principles and lab procedures to test method execution
• Operate lab instruments, observe, calculate and record results
• Characterize microsphere-based devices for structural and chemical properties
• Quality assurance testing of implantable devices to ensure conformance to design specs
• Plan and conduct R&D activities to define and develop implantable microsphere devices
• Assist in development of prototype implantable devices to demonstrate technical feasibility
• Assist in new product development and cost-reduction design activities
• Write technical documentation including process descriptions and test methods
• Manage laboratory equipment, tools, and materials
• Manage installation of new lab equipment with vendors and per FDA quality requirements
• Contribute to and maintain FDA DHF
• Support process improvements for FDA 510(k), QSR and ISO 13485
• Participate in complaint investigations and failure analysis
• Provide root cause analysis and drive corrective actions
• Perform other duties as assigned

Skills

Laboratory experience

Lab software familiarity

Regulatory knowledge

Test procedures development

Education

Associate or 4-year degree in biology/chemistry/physics

Tools

Laboratory equipment management

Job description

Siemens Healthineers seeks an R&D Lab Technician to join our Interventional Oncology team in Austin, Texas. The role focuses on testing, analysis, and development of embolics devices, with emphasis on process development and DHF documentation.

Ideal candidates hold an associate or 4-year degree in biology/chemistry/physics and 2+ years in a regulated lab, with familiarity of FDA QSR/ISO 13485 preferred. Join us to help deliver breakthrough healthcare solutions in a diverse, global environment.