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Engineer - Complaints Technical Investigator

$40 - $45 per hour

Crystal Equation Corporation

Job Overview Engineer Hybrid Summary: Our company is currently seeking a complaints investigation technical investigator in our Complaints Technical Investigations group. This position reports to the Sr. Manager in the Complaints Technical Investigations group. The role is part of a diverse team working to continuously improve our clinical and commercial drug delivery devices to ensure supply and optimize the patient experience. Responsibilities Perform device assessments of complaint samples using lab equipment such as CT scanners and Instron testing machines. Author assessment reports and communicate findings to management and cross‑functional teams. Ensure validity and integrity of evaluation reports. Support investigations by performing characterization testing, data gathering, and analysis. Lead and support root cause analysis for mechanical and/or electromechanical products. Implement, validate, and operate lab equipment; provide personnel training and develop updating procedures. Participate in monthly lab safety inspections and report maintenance or repair needs. Work with vendors to resolve equipment issues and suggest improvements. Provide laboratory and investigative equipment requirements to device development teams for new platforms. 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. Master’s or Bachelor’s in Engineering, Science or Biomedical. Minimum 2+ years of experience in complaints investigation within a development, manufacturing, post‑market or equivalent environment. Experience in a lab environment. Demonstrated competency in root cause analysis methodology. Experience with assessment writing, process and test development and execution, and writing SOPs. Strong technical writing and interpersonal skills. Results‑driven, detail‑oriented, with a strong sense of responsibility and time management. Pay & Benefits Pay range is $40 – $45 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401(k), parental leave, and more. Compensation reflects the cost of labor across several U.S. geographic markets and may vary based on market location, knowledge, skills, and experience. #J-18808-Ljbffr Crystal Equation Corporation

Vacancy posted 2 days ago
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