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Engineer, Complaints Technical Investigator, Medical Devices (JP15046)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer, Complaints Technical Investigator, Medical Devices (JP15046)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Investigations
Employment Type: Contract
Duration: 12 months (with likely extensions and/or conversion to permanent!)
Rate: $36 - $42/hour W2 with Benefits
Posting Date: 2/19/2026
Notes: NO RELOCATION CANDIDATES - Local role, hybrid onsite to ATO is required 3 times per week.
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.
The ideal candidate for this role will have at least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices. They should be proficient with ISO systems, risk analysis processes, and protocol or report writing. A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered. Experience working in biohazard lab settings is a plus, but not mandatory. Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
Candidates must have a background in medical devices, biotech, or biopharma industries and must be local, able to commute onsite 2–3 days per week (ideally residing within Los Angeles, Orange, or Ventura Counties). This role will begin as a one-year contract, with the potential for extension.
Job Description:
Seeking an Engineer - Complaints Technical Investigator supporting Complaints Trending and Investigation group, a diverse team working to continuously improve clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.
The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of client’s packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.
JOB RESPONSIBILITIES:
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
Top Must Have Skill Sets:
Supplement additional workload on team.
Red Flags: Must be local. No relocation.
Interview Process:
Three members of CTI/Complaints/Operations | All Virtual Meetings
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.
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Investigations
Employment Type: Contract
Duration: 12 months (with likely extensions and/or conversion to permanent!)
Rate: $36 - $42/hour W2 with Benefits
Posting Date: 2/19/2026
Notes: NO RELOCATION CANDIDATES - Local role, hybrid onsite to ATO is required 3 times per week.
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.
The ideal candidate for this role will have at least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices. They should be proficient with ISO systems, risk analysis processes, and protocol or report writing. A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered. Experience working in biohazard lab settings is a plus, but not mandatory. Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
Candidates must have a background in medical devices, biotech, or biopharma industries and must be local, able to commute onsite 2–3 days per week (ideally residing within Los Angeles, Orange, or Ventura Counties). This role will begin as a one-year contract, with the potential for extension.
Job Description:
Seeking an Engineer - Complaints Technical Investigator supporting Complaints Trending and Investigation group, a diverse team working to continuously improve clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.
The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of client’s packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.
JOB RESPONSIBILITIES:
- Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
- Provide input to engineering for product improvements
- Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
- Lead root cause analysis to identify the failure mode for client’s products and associated components due to product complaint
- Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, “5 Whys”, risk assessments such as FMEA’s, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
- Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
- Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
- Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.
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 Degree in Science
- 5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
- Understand customer / patient use of client’s packaged and/or distributed products
- Understand manufacturing processes for client’s packaged and/or distributed products
Proven experience with medical devices - Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
- Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
- Experience with protocol and report writing, process and test development and execution, and design of experiments
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
- Strong technical writing and interpersonal skills
Top Must Have Skill Sets:
- Experience with protocol and report writing, process and test development and execution, and design of experiments
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
- Strong technical writing and interpersonal skills
Supplement additional workload on team.
Red Flags: Must be local. No relocation.
Interview Process:
Three members of CTI/Complaints/Operations | All Virtual Meetings
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.
Regards,
3KC Talent Acquisition Team