ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Irving, TX currently has an opportunity for Principal Systems Integration Specialist
WHAT YOU’LL DO
Defines and documents critical sub-system performance requirements that link to system design across interacting functions, (i.e., hardware, software, labeling and/or assay) · Identifies, confirms and interprets interacting cause & 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 complex 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 · Application of advanced Risk Management techniques to a non-conforming product, regulatory or customer notifications. Develops product Risk Analysis.
- Writes and executes 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 all system & assay functions (hardware and software or hardware and assay performance problems).
- Advanced proficiency in the assay applications, operation of instrument, software operating systems, and repair/replacement of parts/subassemblies.
- Responsible for developing departmental/site procedures.
- 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.
Receives little detailed or general direction; exercises considerable discretion as to personal work details as well as the work details of other technical personnel. Creates and reviews project timelines and task sets; recommends resource allocations against project plans and timelines and impact of project scope changes. Reviews, generates and approves related inputs such as protocols and plans. Devises or recommends changes to departmental and/or site level procedures that interpret the intent of the QSR.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelors degree in Life Science or closely related discipline is necessary
- 6-10 years work related experience
- Knowledge of external regulations and standards affecting IVDs and Biologics
- Good Lab Practice, PC Skills (Word, Excel, Powerpoint)
- PhD in Chemistry (Analytical, Physical or related) preferred
- Research or industry experience in electrochemistry preferred, specifically with Ion-Specific Electrodes (ISE) or potentiometric technologies
- Prior medical device (IVD) experience with knowledge of regulation and standards as they pertain to the design, integration, evaluation and commercialization of diagnostic systems
- Demonstrates use of statistics, Design of Experimentation, Six Sigma method, FEMA Cause and Effect or Fishbone Diagram, DOORS, Excel, Powerpoint, Word