Associate Engineer, Biotech Product Complaint (JP13929)
$66,560–$74,880 year
On-siteThousand Oaks, California, United States
Job Summary
Perform device assessments of complaints using CT scanners, microscopes, and measurement equipment in a laboratory environment, documenting results in formal reports. Execute root cause analysis investigations for mechanical and electromechanical products, gathering data and supporting characterization testing. Author evaluation reports and communicate findings to management and cross-functional teams while maintaining report validity. Manage lab infrastructure by implementing equipment procedures, conducting safety inspections, and coordinating vendor repairs. Provide equipment requirements to device development teams for new platforms. Onsite 80% of the time with availability for additional onsite work as needed.
Required 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 lab environment
- Demonstrated competency in root cause analysis methodology
- Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
- Strong technical, analytical and problem-solving skills
- Strong interpersonal, communication, and teamwork skills
- Skills and experience in lab environment
- Onsite 80%, must be available to go onsite when needed
- Must be local to be onsite
Desired Qualifications
- Experience with CT scanner, SEM material analysis, and Instron testing machines
- Experience supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis
- Supporting the implementation, validation, and operation of the equipment in the CT&I lab
- Providing personnel training on the use of the equipment
- Developing and updating equipment procedures
- Participating in the monthly lab safety inspection
- Identifying and reporting equipment repairs or maintenance
- Working with the vendor to resolve issues and suggest improvements associated with the operation of the equipment
- Maintaining close interaction with the quality complaints owner
- Authoring the assessment report and communicating the findings and results to management and cross-functional team as required
- Ensuring the validity and integrity of the evaluation reports
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