Laboratory Technician

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

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.

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

Qualifications & Experience

• 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
• 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 regulatedmedical devicesor combination products is preferred
• Experience with design verification & validation is preferred
• Able to define and develop test procedures and to perform design verification
• Assist with experiments, equipment management, and testing for embolics products.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$65,590 - $90,189

Factors which may affect starting pay within this