Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15323)
About The Position
This position is for a complaints investigation technical investigator in the Complaints Trending and Investigation group. The group works to continuously improve clinical and commercial drug delivery devices to ensure supply and optimize the patient experience. The investigator will perform device assessments of complaint samples using lab equipment, author assessment reports, and communicate findings to management and cross-functional teams. They will ensure the validity and integrity of evaluation reports and interact closely with the quality complaints owner. Responsibilities also include supporting investigations through characterization testing, data gathering and analysis, and root cause analysis. Additionally, the role involves supporting the implementation, validation, and operation of lab equipment, training personnel, developing procedures, and participating in lab safety inspections.
Requirements
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- Experience in lab environment
- Able to collaborate and communicate with cross functional team
- Experience in technical investigation and root cause analysis
Nice To Haves
- Master’s or Bachelor’s in Engineering, Science or Biomedical
- 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
- Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
- Strong technical writing and interpersonal skills
- Results-driven and detail-oriented
- Strong Sense of Responsibility and Time Management.
- Demonstrated competency in root cause analysis methodology
Responsibilities
- Perform device assessments of complaints and document results in a report.
- Complete evaluation and deliver assessment report on time per company requirements.
- Support the implementation and management of the lab infrastructure, including all equipment used for investigations.
- Provide requirements for lab and investigational equipment to device development teams in support of new device platforms.
- Support characterization testing and data gathering for investigations.
- Perform root cause analysis investigations for mechanical and/or electromechanical products.
Benefits
- W2 with Benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
