Senior Engineer - Complaints Technical Investigations

Role: Senior Engineer - Complaints Technical Investigations at Amgen, focusing on analyzing and resolving product complaints related to drug delivery devices. Responsibilities include leading root cause analysis, performing failure investigations using tools like FMEA and Fishbone diagrams, conducting trend analyses, evaluating returned products, and developing design solutions to reduce complaints. The role also involves generating detailed investigation reports, supporting product improvement initiatives, and mentoring staff. Qualifications: Doctorate or Master's with 2+ years, or Bachelor's with 4+ years of operations experience; preferred candidates have 10+ years of experience in failure analysis within medical device development or manufacturing, especially Class II/III devices, with expertise in risk management per ISO 14971 and Six Sigma methodologies. High-value biopharma specifics: Medical devices, failure investigations, root cause analysis, risk management, and complaint trend assessment. Collaboration involves engineering and quality functions for continuous improvement. The role is based at Amgen, with no specific travel requirements mentioned.