Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
* Defines and documents critical performance requirements that link to system design across interacting functions, (i.e., hardware, software,labeling and/or assay)
* Identifies, confirms and interprets interacting causes & effects behind instrument issues, discrepancies, problems or complaints in accordance with governing procedures.
* Devises root cause hypotheses and confirms instrument issues, discrepancies, problems or complaints in accordance with governing procedures.
* Develops or provides input into moderate complexity project plans and timelines.
* Develops and executes system related (i.e., hardware, software,labeling and/or assay) verification & validation and/or characterization protocols and develops and interprets complex written data package summaries in accordance with governing procedures.
* Defines investigative paths for and confirms Complaint Handling investigations to closure.
Additional Main Responsibilities:
* Writes and executes moderately complex system related (i.e., hardware, software, labeling and/or assays) verification and/or characterization protocols including acceptance criteria, analyzes data, write data summaries in accordance with governing procedures.
* Advanced troubleshooting of customer complaints in accordance with governing procedures.
* Advanced troubleshooting across multiple system functions (hardware and software or hardware and assay performance problems).
* Advanced proficiency in operation of instrument, software operating systems, and repair/replacement of parts/subassemblies.
* Responsible for implementing and maintaining the effectiveness of the ADD quality system.
* Applies quantitative methods, analyzes data, evaluates results, forms conclusions and provides/implements improvements.
* Bachelor's degree in Life Science, Engineering, or closely related discipline is desired; or or relevant combination of education or experience.
* 4-6 years' work-related experience.
* Knowledge of external regulations and standards affecting IVDs and Biologics.
* Good Lab Practice, PC Skills (Word, Excel, PowerPoint); Data representation.
* Reviews, generates and documents Verification & Validation or characterization related inputs. · Demonstrates use of statistics, Design of Experimentation, Six Sigma method, FEMA Cause and Effect or Fishbone Diagram, DOORS, Excel, PowerPoint, Word.
* ID Critical Performance Requirements Based on Customer Needs (QFD, benchmarking)
* Optimizes processes: set targets, ranges and specs - DOE, Guard band, Tolerance analysis, Capability (CPk), Test Method development, determine manufacturability / FPA.
* Presents, delivers and interprets information amongst product team members, scientists, engineers, and other systems development personnel.
* Moderate knowledge of external regulations and standards affecting IVDs and Biologics.
* Proficient in operation of instruments and repair/replacement of parts/subassemblies.
* Proficient in moderately complex Project management.
JOB FAMILY:Product Development
LOCATION:United States > Irving : LC-02
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf