Aptask Global Workforce (AGW) is seeking an Engineer - Complaints Technical Investigator for a Hybrid position (3 days onsite) with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity. This role focuses on performing complaints handling and failure analysis investigations for Class II and Class III medical devices. The Engineer will conduct forensic evaluations of complaint units, help with Root Cause Analysis, and contribute to the setup and validation of investigation lab infrastructure. This position requires a combination of remote work and onsite presence 2-3 times per week.
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 products and associated components
- Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, 5 Whys, and risk assessments (FMEAs, Fault Tree Analysis)
- Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis
- Generate final reports in accordance with established procedures, which may include data collection and statistical analysis
- Assist with investigations lab equipment setup, develop and provide equipment training, validate test methods, and develop SOPs for equipment use
Requirements: - Bachelor's degree and 2 years of experience OR an Associate degree and 6 years of experience OR High school diploma/GED and 8 years of experience
- At least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment (Class II or III)
- Experience with protocol and report writing, process and test development and execution, and design of experiments
- Strong technical writing and interpersonal skills
- Experience in leading continuous improvement activities
- Must be local and able to commute onsite 2-3 days per week
Desired skills: - Master's Degree in Science
- Proficiency with ISO systems and risk analysis processes
- Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA)
- Demonstrated Six Sigma proficiency for root cause analysis methodology
- Experience working in biohazard lab settings
Pay range: up to $47.34 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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