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Associate Engineer, Biotech Product Complaint

3 Key Consulting

Associate Engineer, Biotech Product ComplaintLocation: Thousand Oaks, CA. 91320 - HybridBusiness Unit: Complaints TrendingEmployment Type: ContractDuration: 1+ years with possible extensions or conversion to FTERate: $32 - $36/hour W2Notes: Must be local to be onsite.Job Description:Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer in the Complaints Trending and Investigation group. In support of the 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 patient experience.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's 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.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.Top Must Have Skill Sets:Strong technical, analytical and problem-solving skills.Strong interpersonal, communication, and teamwork skills.Skills and experience in lab environment.Day to Day Responsibilities:Perform device assessments of complaints using equipment such as CT scanner, microscope and other measurement/imaging equipment in a laboratory environment and document results in a report.Onsite 80%, must be available to go onsite when needed.Why is the Position Open? Supplement additional workload on teamRed Flags: Short timer employment No technical or engineering experience/educationInterview Process:1st phone interview with hiring manager2nd virtual interview with hiring manager and team.We invite qualified candidates to send your resume to 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Vacancy posted 3 days ago
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