ApTask Global Workforce (AGW) is seeking an Engineer with a Biotechnology company. This is a 12+ month contract opportunity with our client located in Thousand Oaks, CA. This is Hybrid position. Summary: This role is part of a Complaints Trending and Investigation group focused on improving clinical and commercial drug delivery devices. The Engineer will conduct forensic evaluations of complaint units, focusing on product design and usability issues, and contribute to root cause analysis, investigation lab infrastructure, and test method development.
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
- Lead root cause analysis to identify the failure mode for products and associated components due to product complaint
- Perform failure analysis using processes and tools such as fishbone diagrams, 5 Whys, and risk assessments like FMEAs or Fault Tree Analysis
- Lead cross-functional ideation of design solutions to reduce complaints
- 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 to personnel, develop and validate test methods, and develop SOPs for equipment use
Requirements: - Bachelor's degree in Engineering or Sciences (Chemistry, Physics, Biology) and 2+ years of experience, OR Associate's degree and 6+ years of experience, OR High school diploma/GED and 8+ years of experience
- 5+ years of experience performing complaints handling and failure analysis investigations within a medical device environment (Class II or III preferred)
- Experience with protocol and report writing, process and test development and execution, and design of experiments
- Experience in leading continuous improvement activities
- Strong technical writing, verbal communication, and interpersonal skills
- Must be 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, please apply! 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.
#INDAGW
Never miss an opportunity! Create an alert based on the job you applied for.