Medical Device Complaint Investigation & Failure Analysis Engineer; Class II​/III Devices JP

Job Title: Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices)

Location: Thousand Oaks, CA (Hybrid)

Employment Type: Contract

Business Unit: Complaints Trending Group

Duration: 1+ year (potential extensions or transition to permanent)

Pay Rate: $42‑$47/hour W2

The ideal candidate will have at least five years of experience performing complaints handling and failure analysis investigations in a medical device environment, specifically Class II or III devices. They should be proficient with ISO systems, risk analysis processes, and protocol or report writing. A bachelor’s degree in engineering or sciences (chemistry, physics, biology) is strongly preferred; candidates with other educational backgrounds who possess robust laboratory experience will also be considered.

Experience working in biohazard laboratory settings is a plus. Excellent written, verbal, and presentation skills are essential, as the role involves frequent 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.

Requires a combination of remote work and onsite presence 2–3 times per week for complaint returns assessment and laboratory equipment setup, development, and validation of test methods.

• 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 failure modes for client products and associated components due to product complaints.
• Perform failure analysis using tools such as fishbone diagrams, 5 Whys, risk assessments (FMEA, Fault Tree Analysis, 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, determine feasibility through testing and analysis, and develop business plans for implementation.
• Generate final reports in accordance with established procedures, including data collection and statistical analysis.
• Assist with lab equipment setup, provide training to personnel, develop and validate test methods, and create SOPs for equipment use.

• Master's degree or Bachelor’s degree with 2 years of experience, or Associate degree with 6 years of experience, or high school diploma/GED with 8 years of experience.

• 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 (Class II and Class III).
• Understanding of customer/patient use of client products.
• Understanding of manufacturing processes for client products.
• Proven experience with medical devices.
• Demonstrated Six Sigma proficiency for root cause analysis methodology.
• Experience with risk management per ISO 14971, including System Risk Analysis, User Risk Analysis, DFMEA/FMEA, and related tools.
• Proficiency in protocol and report writing, process and test development and execution, and design of experiments.
• Experience leading continuous improvement activities by implementing process and product quality improvement initiatives.
• Strong technical writing and interpersonal skills.

To apply, send your resume to