Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15557)

3 Key Consulting

  • Thousand Oaks, California
  • 6 days ago
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    Skills

    • Automotive Industryunmatched
    • Automotive Manufacturingunmatched
    • Automotive Repair and Maintenanceunmatched
    • Biomedicineunmatched
    • Biotech and Pharmaceuticalunmatched
    • Communication Skillsunmatched
    • Consultingunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Data Analysisunmatched
    • Data Collectionunmatched
    • Detail Orientedunmatched
    • Drug Delivery Devicesunmatched
    • Electromechanicsunmatched
    • Equipment Maintenance/Repairunmatched
    • High School Diplomaunmatched
    • Interpersonal Skillsunmatched
    • Laboratoryunmatched
    • Laboratory Equipmentunmatched
    • Laboratory Managementunmatched
    • Manufacturingunmatched
    • Medical Equipmentunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Root Cause Analysisunmatched
    • Specimens/Samplesunmatched
    • Staff Trainingunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Supplier Optimizationunmatched
    • Team Lead/Managerunmatched
    • Team Playerunmatched
    • Technical Recruitingunmatched
    • Technical Writingunmatched
    • Test Dataunmatched
    • Test Plan/Scheduleunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Training/Teachingunmatched
    • Writing Skillsunmatched

    Description

    Job Title: Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15557)
    Location: Thousand Oaks, CA. 91320
    Business Unit: Complaints Investigations
    Employment Type:  Contract
    Duration: 12 months with likely extensions and/or conversion to permanent
    Rate: $40 - $46/hour W2 with Benefits
    Posting Date: 07/14/2026
    Notes: Onsite 80%, must be available to go onsite when needed. Preferably Local candidates

    3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. automotive manufacturing and services company.

    Job Description:
    seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr. Engineer in Complaints Trending and Investigation group. In support of company’s 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 lab equipment such as the CT scanner 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 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.

    JOB RESPONSIBILITIES:
    • Perform device assessments of complaints and document results in a report.
    • 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
    • Perform root cause analysis investigations for mechanical and/or electromechanical products 

    Basic Qualifications
    Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of 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
    • 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
    • Strong Sense of Responsibility and Time Management.
    • Demonstrated competency in root cause analysis methodology
       
    Top Must Have Skill Sets:
    • Experience in lab environment
    • Able to collaborate and communicate with cross functional team
    • Experience in technical investigation and root cause analysis
     
    Day to Day Responsibilities:
    • Perform device assessments of complaints return units in Lab and document results in a report.
    • 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
    • Perform root cause analysis investigations for mechanical and/or electromechanical products (as needed)

    Why is the Position Open?
    Supplement additional workload on team.

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

    Interview Process:
    Phone screening (15-30 min with hiring manager)
    Video call / interview with cross-functional team (3-4 members, ~30-45 mins)

    We invite qualified candidates to send your resume to 

    resumes@3keyconsulting.com

    .  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
     

    Numbers & Facts

    LocationThousand Oaks, California
    Website3keyconsulting.com/careers

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