TekOne IT Services Pvt. Ltd.
Hiring : Senior Scientist/ Technical Document Writer
TekOne IT Services Pvt. Ltd., San Diego, California, United States, 92189
Role:
Sr. Scientist/Technical Document WriterLocation:
San Diego, CA - 92121Duration:
1 Year on W2Job Description
Working w/ Medical Technology and Software background.Must be very familiar with all Cell Din systems to set up the systems, collect data and analyze the collected data.Must also be familiar with blood cell morphology to be able to collect reference data.Must be able to conduct experiments with minimum supervision to develop CDX Cal/Con.Must be able to analyze RBC Morphology data using the 3D surface analysis software program (software knowledge in addition to medical technology and Cell Din systems knowledge required).Must have a good understanding in clinical applications of Cell Din methods.Assay Development/Verification and Technical Writing- Needs to have experience with verification and validation of existing assays.Will also be working in assay development.Writing and editing technical documents including requirements documents, specification documents, design history files, verification and validation protocols and reports, etc.Reviews Design Control documentation to assess compliance to processes and procedures and works with teams to address and correct deficiencies.Technical Writing: Write and edit technical documents including requirements documents, specification documents, verification and validation documents, Failure Modes and Effects Analysis (FMEA) documents, Design Planning documents, and Design Review records in a manner that will achieve accuracy and avoid errors.Convert relevant product data and information into a form that meets Quality and submission requirements.Utilize electronic Product Lifecycle Management (PLM) system to query, view, edit, and print technical documentation.Utilize Product Data Management (PDM) system to assist with storing, accessing, and editing design data and engineering files (e.g. bill of materials, drawings, etc).The output provided by the incumbent/candidate is subject to external audit (e.g. FDA, ISO). The lack of accuracy and timeliness will impact the Quality system at site and division levels.Basic Qualifications
Bachelor's Degree in English, Writing, Technical Communications or Engineering with 6 years of experience.A minimum of 3 years of relevant experience in a related area such as R&D Technical Product Development or Quality in the healthcare industry.Writing, editing, and managing technical documentation utilized in the development of new products and improvement of existing products.Developing spreadsheets or databases for the capture, assembly, and graphical presentation of metrics is required.Knowledge of division products and Quality systems, system linkages, and quality measures is desirable.
#J-18808-Ljbffr
Sr. Scientist/Technical Document WriterLocation:
San Diego, CA - 92121Duration:
1 Year on W2Job Description
Working w/ Medical Technology and Software background.Must be very familiar with all Cell Din systems to set up the systems, collect data and analyze the collected data.Must also be familiar with blood cell morphology to be able to collect reference data.Must be able to conduct experiments with minimum supervision to develop CDX Cal/Con.Must be able to analyze RBC Morphology data using the 3D surface analysis software program (software knowledge in addition to medical technology and Cell Din systems knowledge required).Must have a good understanding in clinical applications of Cell Din methods.Assay Development/Verification and Technical Writing- Needs to have experience with verification and validation of existing assays.Will also be working in assay development.Writing and editing technical documents including requirements documents, specification documents, design history files, verification and validation protocols and reports, etc.Reviews Design Control documentation to assess compliance to processes and procedures and works with teams to address and correct deficiencies.Technical Writing: Write and edit technical documents including requirements documents, specification documents, verification and validation documents, Failure Modes and Effects Analysis (FMEA) documents, Design Planning documents, and Design Review records in a manner that will achieve accuracy and avoid errors.Convert relevant product data and information into a form that meets Quality and submission requirements.Utilize electronic Product Lifecycle Management (PLM) system to query, view, edit, and print technical documentation.Utilize Product Data Management (PDM) system to assist with storing, accessing, and editing design data and engineering files (e.g. bill of materials, drawings, etc).The output provided by the incumbent/candidate is subject to external audit (e.g. FDA, ISO). The lack of accuracy and timeliness will impact the Quality system at site and division levels.Basic Qualifications
Bachelor's Degree in English, Writing, Technical Communications or Engineering with 6 years of experience.A minimum of 3 years of relevant experience in a related area such as R&D Technical Product Development or Quality in the healthcare industry.Writing, editing, and managing technical documentation utilized in the development of new products and improvement of existing products.Developing spreadsheets or databases for the capture, assembly, and graphical presentation of metrics is required.Knowledge of division products and Quality systems, system linkages, and quality measures is desirable.
#J-18808-Ljbffr