Job Description

Job Title: Associate Engineer/Complaints Investigation

Location: Thousand Oaks CA

Duration: 12 Months

Description:

***Onsite 80%, must be available to go onsite when needed***

Expectation is that they will need to be onsite.

***Local candidate***

Top 3 Must Have Skill Sets:

1) Strong technical, analytical and problem solving skills

2) Strong interpersonal, communication, and teamwork skills

3) Skills and experience in lab environment

Amgen is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer in Complaints Trending and Investigation group. In support of Amgen’s mission to serve patients, the Complaints Trending and Investigation group at Amgen is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis.

S/he will also support 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, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Responsibilities:

• Perform device assessments of complaints and document results in a report.

• Perform root cause analysis investigations for mechanical and/or electromechanical products

• Complete evaluation and deliver assessment report on time per Amgen 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

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 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 writing and interpersonal skills

• Results-driven and detail-oriented

Basic Qualifications

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

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