Abbott→
Analyst I, Product Surveillance at Abbott · United…
Entry LevelOn-siteFull-timeUnited States - Minnesota - Plymouth$51k–$101k/yr
Skills
medical device evaluationnon-destructive testingdestructive testingmicroscopydevice history record analysisquality system complianceregulatory knowledge - medical device reportingcomputer proficiencyindependent work
Job Description
Summary: Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Analyst I, Product Surveillance position involves conducting evaluations on returned complaint products, performing testing to assess device performance, and documenting analysis results to support complaint investigations.
Responsibilities:
- Conduct evaluations on returned complaint products, including disposable, implantable, electronic, and electro‑mechanical medical devices and systems
- Perform non‑destructive and destructive testing to assess device performance and failure modes
- Physically inspect devices using laboratory tools and microscopy to replicate reported product issues
- Review and analyze Device History Records (DHRs) to support complaint investigations
- Document and enter analysis results and observations into the designated quality/compliance systems
- Prepare clear, detailed technical reports summarizing evaluation methods, findings, and conclusions
- Coordinate testing and analysis activities with cross‑functional internal departments and external consultants
- Operate, maintain, and ensure proper use of Postmarket Surveillance Laboratory equipment
- Support compliance with quality system and regulatory requirements through thorough documentation and testing practices
Required Qualifications:
- Four-year degree, preferably in the healthcare, science, or technical fields
- Strong written and oral communication skills are required
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
- Good problem-solving and proficient computer skills are required
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Preferred Qualifications:
- Knowledge of global regulations for medical device reporting and medical terminology is a plus
Required Skills: Medical Device Evaluation, Non-destructive Testing, Destructive Testing, Microscopy, Device History Record Analysis, Quality System Compliance, Regulatory Knowledge - Medical Device Reporting, Computer Proficiency, Independent Work
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.
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.