Engineer

Thousand Oaks, CA 91320

Posted: 05/18/2023 Job Number: 37444

Job Description


Pay range is $32 - $37 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

 

Engineer

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:    
  • Experience in technical investigation and root cause analysis
  • Master’s or Bachelor’s in Engineering, Science or Biomedical
  • Experience in lab environment
  • Able to collaborate and communicate with cross functional team

Red Flags:    
  • No technical background or experience
  • Lack of basic technical qualifications and must have skills
  • Inability to commute to Thousand Oaks Facility

Summary:

Our company is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr Manager in Complaints Trending and Investigation group. In support of our mission to serve patients, the Complaints Trending and Investigation group 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 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

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

Meet Your Recruiter

Scott Brasel

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