Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) - (JP15376)

3 Key Consulting•Thousand Oaks, CA

1d•Hybrid

About The Position

3 Key Consulting is hiring a Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) for a consulting engagement with our direct client, a leading global biopharmaceutical company. 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. This role will begin as a one-year contract, with the potential for extension. 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.

Requirements

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.
Proficient with ISO systems, risk analysis processes, and protocol or report writing.
Excellent written and verbal communication skills, along with strong presentation abilities.
Background in medical devices, biotech, or biopharma industries.
Must be local, able to commute onsite 2–3 days per week (ideally residing within Los Angeles, Orange, or Ventura Counties).
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
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

Nice To Haves

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.
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)

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.
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.