System Integration Specialist

Abbott • Sunnyvale, CA

2d • $61,300 - $122,700 • Hybrid

About The Position

This position works out of our Sunnyvale, CA or Irving, TX location in the diagnostics division. The main purpose of this role is to develop and execute 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. Will identify and confirm causes behind instrument issues, discrepancies, problems or complaints in accordance with governing procedures. Will also devise 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.

Requirements

• Bachelors Degree (± 16 years) in Life Science or closely related discipline is desired or an equivalent combination of education and work experience.
• Minimum 2 years work related experience.
• Familiarity with clinical laboratory environments, workflows, and operational practices.
• Hands on experience working with human specimens, including appropriate handling, and processing considerations.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Reviews, generates and documents Verification & Validation or characterization related inputs.
• Demonstrates use of experimental and data Analysis techniques including statistics, DOE and Six Sigma training.
• 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.
• Good Lab Practice, PC Skills (Word, Excel, Powerpoint); Data representation.

Nice To Haves

• Exposure to blood testing, with hematology experience preferred.
• Understanding of laboratory safety practices and specimen integrity considerations when working with clinical samples preferred.

Responsibilities

• Writes and executes moderately complex system related (i.e., hardware, software, labeling and/or assays) verification and/or characterization protocols, analyzes data, writes data summaries in accordance with governing procedures.
• Moderate troubleshooting of customer complaints in accordance with governing procedures.
• Moderate troubleshooting across multiple system functions (i.e., hardware and software. hardware and assay performance problems).
• Moderate proficiency in operation of instrument, 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.
• Receives general direction; exercises moderate discretion as to personal work details.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level