Medical Device Complaint & Failure Analysis Engineer - (JP15808)

3 Key Consulting•Thousand Oaks, CA

3d•Hybrid

About The Position

3 Key Consulting is hiring an Medical Device Complaint & Failure Analysis Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. The ideal candidate for this role will have: 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices; Proficiency 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 be local, able to commute onsite 3 days per week, or more if needed (ideally residing within Los Angeles, Orange, or Ventura Counties). Our client is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Technical Investigations group. The Engineer - Complaints Technical Investigator will perform the device assessment of complaint units 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 Engineer - Complaints 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. This position is open to supplement additional workload on the team.

Requirements

5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices
Proficiency 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
Excellent written and verbal communication skills
Strong presentation abilities
Candidates must be local, able to commute onsite 3 days per week, or more if needed (ideally residing within Los Angeles, Orange, or Ventura Counties).
Masters Degree OR Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR Associate degree and 6 years of related medical/biopharma development or Operations experience.

Nice To Haves

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
Experience in lab environment
Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
Strong Sense of Responsibility and Time Management.

Responsibilities

Perform the device assessment of complaint units using lab equipment such as the CT scanner and Instron testing machines.
Author the assessment report and communicating the findings and results to management and cross-functional team as required.
Maintain close interaction with the quality complaints owner.
Support investigations by performing characterization testing, data gathering and analysis.
Support/lead root cause analysis.
Support the implementation, validation, and operation of the equipment in the lab.
Provide personnel training on the use of the equipment.
Develop and update equipment procedures.
Participate in the monthly lab safety inspection.
Identify and report equipment repairs or maintenance.
Work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
Lead evaluation of returned products, perform detailed assessments, and document results in a report.
Complete evaluations and deliver assessment report on time per client 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 investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.
Perform root cause analysis investigations for mechanical and/or electromechanical products.