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About the Role
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
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
- 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
- Must be able to work with controlled technology in accordance with US export control law.
Skills
- microscopy
- FTIR
- HPLC
- general chemical and microsphere analysis methods
- laboratory equipment management
- laboratory software
- FDA & MDD
- QSR & ISO 13485
- Quality System
- design verification & validation
- test procedures
- design verification
Location
- global
Work Type
- full-time
Experience Level
- 2+ years of laboratory experience
Education Level
- Associate or 4-year degree preferred in biology, chemistry, or physics
Salary/Compensations
- $56,550 - $77,759
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
About the Company
- 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.
- 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.
Equal Opportunity
- Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
- Applicants and employees are protected under Federal law from discrimination.
- Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.