Overview Job Title: Engineer, Drug Delivery Device Complaints and Investigations (JP14565) | Location: Thousand Oaks, CA 91320 - Hybrid | Business Unit: Complaints Investigation | Employment Type: Contract | Duration: 1+ years with possible extensions or conversion to FTE | Rate: $38 - $42/hour W2 with benefits | Posting Date: 09/24/2025 3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. The project involves investigations of complaints for device delivery systems and related reporting in support of patient safety and product quality. 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. Top Must Have Skill Sets Technical background preferably in a GxP setting. Laboratory experience – comfort with technical testing. Strong technical writing and interpersonal skills. 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 a 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. Strong sense of responsibility and time management. Basic Qualifications Master’s degree and 3 years of related medical/biopharma development or Operations experience; OR Bachelor’s degree and 5 years of related medical/biopharma development or Operations experience. Additional Qualifications (Preferred) Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical. 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment. Experience with statistics and statistical analysis. Demonstrated competency in root cause analysis methodology. Experience with protocol and report writing, process and test development and execution, and writing SOPs. Strong technical writing and interpersonal skills. Results-driven and detail-oriented team leader. Other considerations Why is the Position Open? Supplement additional workload on team. Interview Process: Virtual Interview; Interview with Hiring Manager; Panel Interview with team. Important notes We invite qualified candidates to send their resume to resumes@3keyconsulting.com. Additional positions may be available at #J-18808-Ljbffr 3key Consulting, Inc.
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