Laboratory Technician

Siemens Healthineers

31d

About The Position

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 seeking an R&D Lab Technician 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 assisting with testing, analysis, process development, equipment management, and lab management related to new and existing microsphere products. The ideal candidate would be a self-driven individual with a passion for implantable therapies and a desire to work on products that change people’s lives.

Requirements

Associate or 4-year degree preferred in biology, chemistry, or physics
2+ years of laboratory experience with preference for experience in medical device or other regulated industry
Equivalent combinations of education and experience may be considered

Nice To Haves

Knowledge of laboratory techniques such as microscopy, FTIR, HPLC, and general chemical and microsphere analysis methods is preferred
Experience with laboratory equipment management is preferred
Experience with laboratory software is preferred
Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry 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
Experience with design verification & validation is preferred
Able to define and develop test procedures and to perform design verification

Responsibilities

Apply basic scientific principles and laboratory procedures to test method execution
Operate laboratory instruments, make observations, 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