Engineer - Complaints Technical Investigator
Amgen
Summary
Amgen is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Amgen's mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience. The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/or usability issues. This role understands customer/patient use of Amgen's packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.
Job description
Job 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 Amgen's products and associated components due to product complaint
- Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, "5 Whys", risk assessments such as FMEA's, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
- Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
- Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
- Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use
Basic Qualifications
- Master's degree OR Bachelor's degree and 2 years of operations experience OR Associate's degree and 6 years of operations experience OR High school diploma / GED and 8 years of operations experience
Preferred Qualifications
- Master's Degree in Science
- 5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
- Understand customer / patient use of Amgen's packaged and/or distributed products
- Understand manufacturing processes for Amgen's packaged and/or distributed products
- Proven experience with medical devices
- Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
- Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
- Experience with protocol and report writing, process and test development and execution, and design of experiments
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
- Strong technical writing and interpersonal skills
Requirements
- Master's degree OR Bachelor's degree and 2 years of operations experience OR Associate's degree and 6 years of operations experience OR High school diploma / GED and 8 years of operations experience
- Master's Degree in Science (preferred)
- 5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III (preferred)
- Understand customer / patient use of packaged and/or distributed products (preferred)
- Understand manufacturing processes for packaged and/or distributed products (preferred)
- Proven experience with medical devices (preferred)
- Demonstrated Six Sigma proficiency specifically for root cause analysis methodology (preferred)
- Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools) (preferred)
- Experience with protocol and report writing, process and test development and execution, and design of experiments (preferred)
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives (preferred)
- Strong technical writing and interpersonal skills (preferred)
Benefits
- Retirement and Savings Plan
- Group Medical Coverage
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time-Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.