Senior Systems Integration Specialist

Company: Abbott Laboratories
Location: Irving
Posted on: January 12, 2021

Job Description:

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 107,000 colleagues serve people in more than 160 countriesABOUT 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 Senior Systems Integration Specialist.WHAT YOU'LL DO Develops and executes system related (i.e., hardware, software, labeling and/or assay) verification & validation and/or characterization protocols and develops written data package summaries in accordance with governing procedures. Identifies and confirms causes 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. Defines investigative paths and confirms Complaint Handling investigations to closure.Responsibilities * 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.* 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.* Technical Leadership and Mentoring - May provide input into moderate to complex project and design plans and timelines.* May participate in hiring process for system integration resources and provide input to System Integration Managers.EDUCATION AND EXPERIENCE YOU'LL BRINGRequired Skills/Knowledge/Experience* Advanced degree in Life or Physical Science, Bioengineering, Biomedical Engineering or closely related discipline is preferred.* 4-6 years' work related experience with degree or sufficient transferable experience to demonstrate functional equivalence to a degree.* Moderate knowledge of external regulations and standards affecting IVDs and Biologics. Good Lab Practice, Good Manufacturing Practice, laboratory duties, PC Skills (Word, Excel, PowerPoint), Data representation.Preferred * 7+ years of relevant work experience* 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.* Identify 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.* Proficient in operation of instruments and repair/replacement of parts/subassemblies.* Proficient in moderately complex Project management.* Experience in highly regulated industry.WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:* Training and career development, with onboarding programs for new employees and tuition assistance* Financial security through competitive compensation, incentives and retirement plans* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs* Paid time off* 401(k) retirement savings with a generous company match* The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Irving , Senior Systems Integration Specialist, Other , Irving, Texas