Engineer, Drug Delivery Device Complaints and Investigations; JP
Listed on 2026-01-23
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Engineering
Biomedical Engineer
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.
- Technical background preferably in a GxP setting.
- Laboratory experience – comfort with technical testing.
- Strong technical writing and interpersonal skills.
- 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.
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.
Why is the Position Open? Supplement additional workload on team.
Interview Process: Virtual Interview;
Interview with Hiring Manager;
Panel Interview with team.
We invite qualified candidates to send their resume to Additional positions may be available at
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