Senior Engineer - Complaints Technical Investigations (Medical Devices)

Location: Thousand Oaks, California, United States

Annual salary: $115,494.60–$156,257.40

Company

Biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead root cause and failure analysis investigations for complaints involving drug delivery products and components.
• Use fishbone diagrams, 5 Whys, FMEA, Fault Tree Analysis, tolerance analysis, and other risk assessment methods.
• Lead cross-functional ideation, testing, and analysis of design solutions to reduce complaints.
• Conduct technical trend and consolidated investigations using statistical and relational data analytics.
• Evaluate returned products, reserve samples, batch records, complaint history, and trends.
• Own CAPA activities, prepare investigation reports, support product improvements, and coach staff.

Requirements

• Doctorate degree; or a master’s degree with 2 years of operations experience; or a bachelor’s degree with 4 years; or an associate’s degree with 8 years; or a high school diploma/GED with 10 years.
• 5+ years of complaints or failure analysis investigation experience in a development or manufacturing environment.
• Proven experience with medical devices, ideally Class II and Class III devices.
• Demonstrated Six Sigma proficiency in root cause analysis methodology.
• Experience with ISO 14971 risk management, including System Risk Analysis, User Risk Analysis, and DFMEA/FMEA.
• Strong technical writing and interpersonal skills, plus experience with protocols, reports, testing, and design of experiments.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time-off programs and career development opportunities.