Medical Device Complaint & Failure Analysis Engineer JP

Medical Device Complaint & Failure Analysis Engineer

3 Key Consulting is hiring a 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).

Day to Day Responsibilities:

• 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

Basic Qualifications:

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.

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
• Experience in lab environment
• Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
• Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
• Strong Sense of Responsibility and Time Management.