Engineer

ApTask Global Workforce (AGW) is seeking an Engineer with a biopharmaceutical company. This is a 12+ month contract opportunity with our client located in Thousand Oaks, CA. This is a hybrid position.

Summary:
This role supports a leading biotechnology company's mission to serve patients by continuously improving clinical and commercial drug delivery devices. The ideal candidate will conduct forensic evaluations of complaint units, focusing on product design and usability issues. This position requires working a hybrid schedule, with 2 to 3 days per week onsite for complaint returns assessment and laboratory work.

Responsibilities:

• Lead the 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
• Perform failure analysis using tools such as fishbone diagrams, 5 Whys, and risk assessments (FMEAs, Fault Tree Analysis)
• Utilize equipment such as CT scanners, Instron tensile test machines, and SEM
• Lead cross-functional ideation of design solutions to reduce complaints
• Generate final reports in accordance with established procedures, including data collection and statistical analysis
• Assist with investigations lab equipment setup, 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 an Associate degree and 6+ years of experience OR a High School diploma/GED and 8+ years of experience
• Master's degree is a plus
• At least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment (Class II or Class III devices)
• Proficiency with ISO systems and risk analysis processes (ISO 14971, FMEA)
• Experience with protocol and report writing, process and test development, and design of experiments
• Strong technical writing, verbal communication, and interpersonal skills
• Must be a local candidate able to commute onsite 2-3 days per week

Desired skills:

• Experience working in a biohazard lab setting

Pay range: Up to $42.52 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.