Job Description
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.
Job Description: Our client is currently 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 at company 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.
Responsibilities include: - 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 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
Preferred Qualifications: - 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 standard operating procedures (SOP)
- Strong technical writing and interpersonal skills
- Results-driven and detail-oriented team leader
Why is the Position Open?Supplement additional workload on team
Red Flags: - Not a local candidate i.e. inability to come on site in Thousand Oaks, CA most days of week
- Non-technical background
- Poor Communication Skills
Interview Process: Virtual Interview
- Interview with Hiring Manager
- Panel Interview with team
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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Job Tags
Contract work, Local area,