Sr. Quality Scientist

Job Description

Organization: Siemens Healthineers
Business Unit: Point of Care
Requisition Number: 247824
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 20%

Job Description:

Are you the right scientist to work in a fast-paced manufacturing environment with cross-functional focus?  You will be involved in supporting a newly established reagent manufacturing system as well as future integration projects within an Immunoassay product line.

 

Duties and Responsibilities:

·        Performs routine to complex tests and analyses according to established procedures

·        Performs complex tests or investigations pertaining to the development of new designs, methods, materials, or processes and investigates possible application of results

·        Troubleshoots and resolves complex problems

·        Completes a wide variety of complex technical assignments.

·        Obtains, correlates, and analyzes technical information needed to accomplish complex tasks

·        Performs mid to complex analysis of raw data to determine experimental results and learns and implements best practices for data analysis 

·        Completes the preparation of reports, charts, graphs, and other documents and advises senior staff

·        Reviews and approves related inputs such as complex drawings and specifications prepared by technical support personnel

·        Plans with support mid-complex to highly complex experiments, including planning reagents and consumables required

·        Works collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups

·        May lead meetings when assigned to continue projects- either for scheduling, troubleshooting, or status collection

·        Leads development of assay parameters (test methods) for use on analytical instrumentation

·        Participates in Design Control activities: Verification and Validations, testing and documentation- from Design Change documentation to authoring protocols and reports with some support as required

·        Works collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups

 

Required Knowledge/Skills, Education, and Experience:

  • B.A. or B.S. Degree in biology or biochemistry with over 6 years of industry experience.  Masters with 4 years industry experience. PhD with 2 years industry experience.
  • Thorough understanding of MDSAP country standard requirements for medical device or pharmaceutical operations

·        Multiple years of experience working with Immunoassay based technology, specifically involving a troponin assay

·        Experience working with analytical instrumentation, reagent systems, including testing repetitively

·        Experience planning experiments with multiple variables – may have been DOE.  This includes identifying all factors and determining replicates needed for statistical significance.

·        Experience identifying and troubleshooting process, material, or equipment problems to minimize down time and recommend solutions

·        Experience performing data analysis as well as formal report writing

·        Experience creating and modifying testing protocols and supporting documents

·        Familiar with statistical analysis tools

·        Able to work independently and manage tasks assigned on schedule

·        Strong scientific, communication and organizational skills are a must

·        Should be comfortable with handling bio-hazardous materials

·        Travel required may be 0-20% depending on Project.

 

Preferred Knowledge/Skills, Education, and Experience:

·     Experience with multiple reagent kits for immunoassay based technologies

·        Experience working with analytical instrumentation, hardware and reagent systems, including testing repetitively

·        Experience planning experiments with multiple variables – may have been DOE.  This includes identifying all factors and determining replicates needed for statistical significance

·     Data analysis using Minitab software

·        Experience with development within regulated environments to support development of IVD and Immunoassay–based clinical assays and instruments is highly desirable

   

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