Test Engineer, Technical Investigator, Medical Device; JP

Position: Test Engineer, Technical Investigator, Medical Device (JP13934)
Location: Newbury Park

Job Title: Test Engineer, Technical Investigator, Medical Device (JP13934)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Trending
Employment Type: Contract
Duration: 12 months with possible extensions or conversion to FTE
Rate
: $36-42 W2 with benefits
Posting Date: 04/12/2025.
Notes: Only qualified candidates need apply. Onsite 80% of time as needed (local candidates).

3 Key Consulting is hiring! We are recruiting an Engineer, Technical Investigator Medical Device for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal candidate:

• 3 years of experience performing failure analysis investigations within a medical device environment, specifically class II or class III devices.
• 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.

Engineer - Complaints Technical Investigator:
Requires a combination of working remote and going onsite 2 to 3 times per week (average) for complaint returns assessment and/or laboratory equipment setup, development and validation of test methods.

Job Description:
Our client is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Company's mission to serve patients, we are 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 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 Company'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.

Top Must Have Skill Sets:

• 3+ years of experience in failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
• 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

Day to Day 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 Company'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.

Basic Qualifications:
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
• 3 years 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 Company's packaged and/or distributed products
• Understand manufacturing processes for Company's packaged and/or distributed products
• Proven…