R&D Lab Technician – Implantable Microsphere Devices

Siemens Healthineers; United States; On-site; USD 66,000 - 90,000; Full time

Job summary

Siemens Healthineers seeks an R&D Lab Technician to join our Interventional Oncology development team, focusing on embolics to treat cancers by implantable microsphere devices. You will assist with testing, data collection, and lab management in a regulated medical device environment.

Join a global team that values curiosity and collaboration, offering growth opportunities and exposure to FDA/QSR/ISO 13485 aligned processes and cutting-edge technologies that aim to improve patient care.

Qualifications

• Associate or 4-year degree preferred in biology, chemistry, or physics.
• 2+ years of laboratory experience in a regulated environment preferred.
• Knowledge of labs techniques such as microscopy, FTIR, HPLC is preferred.
• Experience with lab equipment management and with laboratory software is preferred.
• Familiarity with FDA, QSR and ISO 13485 regulatory issues is preferred.

Responsibilities

• Apply basic scientific principles and laboratory procedures to test method execution.
• Operate laboratory 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 specifications.
• Plan and conduct R&D activities to define and develop implantable microsphere devices, including test execution and basic research.
• Assist in development of prototype implantable devices to demonstrate technical feasibility.
• Assist in new product development projects and cost-reduction design activities.
• Write technical documentation including process descriptions and test methods.
• Manage laboratory equipment, tools, and materials.
• Manage installation of new laboratory equipment with vendors and through Varian quality requirements.
• 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

Laboratory techniques

Microscopy

FTIR

HPLC

Equipment management

Regulatory familiarity

Education

Biology/ Chemistry/ Physics degree

Regulated industry exposure

Tools

Laboratory software

Job description

Siemens Healthineers seeks an R&D Lab Technician to join our Interventional Oncology development team, focusing on embolics to treat cancers by implantable microsphere devices. You will assist with testing, data collection, and lab management in a regulated medical device environment.

Join a global team that values curiosity and collaboration, offering growth opportunities and exposure to FDA/QSR/ISO 13485 aligned processes and cutting-edge technologies that aim to improve patient care.