Engineer

Payrate: $40.00 - $44.00/hr. Summary The complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner and Instron testing machines. The candidate will be responsible for authoring assessment reports and communicating findings to management and cross‑functional teams, ensuring the validity and integrity of these reports. The investigator will maintain close interaction with the quality complaints owner, support investigations by performing characterization testing, data gathering, and analysis, and lead/root‑cause investigations. Additional duties include implementing, validating, and operating lab equipment, training personnel, developing and updating equipment procedures, participating in monthly lab safety inspections, identifying and reporting equipment repairs or maintenance, and working with vendors to resolve issues and suggest improvements related to equipment operation. Responsibilities Perform device assessments of complaints and document results in a report. Complete evaluations and deliver assessment reports on schedule per requirements. Support the implementation and management of the laboratory infrastructure, including all investigative equipment. Provide requirements for laboratory and investigative equipment to device development teams supporting new device platforms. Support characterization testing and data gathering for investigations. Perform root‑cause analysis investigations for mechanical and/or electromechanical products. Basic Qualifications Master’s degree; OR Bachelor’s degree and 2 years of related medical/biopharma development or operations experience; OR Associate degree and 6 years of related medical/biopharma development or operations experience. Preferred Qualifications 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 in a lab environment. Experience with assessment writing, process and test development and execution, and writing standard operating procedures. 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. Top 3 Must Have Skill Sets Experience in a lab environment. Able to collaborate and communicate with cross‑functional teams. Experience in technical investigation and root‑cause analysis. #J-18808-Ljbffr Aditi Consulting