Medical Device Complaint & Failure Analysis Engineer - (JP15808)

3key Consulting, Inc.; Thousand Oaks (CA); Hybrid; USD 56,000 - 63,000; Full time

Job summary

3 Key Consulting is seeking a Medical Device Complaint & Failure Analysis Engineer for a 1+ year contract in Thousand Oaks, CA. Local candidates only with hybrid onsite 3 days per week.

The ideal candidate has 5+ years in complaints handling and failure analysis for Class II/III devices, proficiency with ISO systems and risk analysis, and strong written and verbal communication skills for regular presentations to internal teams.

Qualifications

• 5 years of complaints handling and failure analysis in a medical device environment (class II/III).
• Strong written and verbal communication skills for regular presentations.
• Proficiency with ISO systems and risk analysis processes.

Responsibilities

• Lead evaluation of returned products and document results in a report.
• Support lab infrastructure and equipment, including training personnel.
• Perform root cause analyses for mechanical/electromechanical products.

Skills

Complaint handling

Failure analysis

Communication skills

Education

Bachelor's degree in engineering or sciences

Master's degree in Science

Tools

CT scanner

Instron testing

Job description

Medical Device Complaint & Failure Analysis Engineer - (JP15808)

• Thousand Oaks, CA
• Biotech/Pharmaceutical

Job Title: Medical Device Complaint & Failure Analysis Engineer - (JP15808) Location: Thousand Oaks, CA. 91320 (local candidates only). Employment Type: Contract Business Unit: Complaint Investigations Duration: 1+ year (with likely extensions and/or conversion to permanent) Posting Date: 09/03/26 Pay Rate: $41 - $46/hour W2 Notes: Only qualified candidates need apply. Local Role, hybrid onsite to ATO is required 3 times per week (up to 80%).

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).

Engineer - Complaints Technical Investigator:

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.

Why is the Position Open?

Supplement additional workload on the team

Top Must Have Skills:

• Experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices
• 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

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.

Red Flags:

• 1. No Technical Background or Experience
• 2. Communication Issues and lack of basic qualifications
• 3. Inability to commute to Thousand Oaks several times a week

Interview process:

• Step 1: Phone Screen with Hiring Manager (15-30 mins)
• Step 2: Video Panel Interview with Team (30-45 mins)