Engineer - Complaints Technical Investigator

Amgen•Thousand Oaks, CA

About The Position

Amgen is seeking an Engineer - Complaints Technical Investigator for its Complaints Trending and Investigation group. The role supports the company’s mission to serve patients by helping improve clinical and commercial drug delivery devices, maintain supply, and optimize the patient experience. The investigator conducts forensic evaluations of complaint units for standard and advanced investigations involving product design or usability issues, and develops an understanding of how customers and patients use Amgen products as well as how those products are manufactured. The position also supports root cause analysis, investigation lab infrastructure, equipment setup, and test method development and validation.

Requirements

One of the following: a master’s degree; a bachelor’s degree and 2 years of operations experience; an associate’s degree and 6 years of operations experience; or a high school diploma/GED and 8 years of operations experience.

Nice To Haves

Master’s degree in science.
5 or more years of complaints or failure-analysis investigation experience in a development or manufacturing environment, working with medical devices, ideally Class II and Class III.
Understanding of customer or patient use of Amgen’s packaged or distributed products.
Understanding of manufacturing processes for Amgen’s packaged or distributed products.
Proven experience with medical devices.
Demonstrated Six Sigma proficiency, specifically in root cause analysis methodology.
Experience with risk management per ISO 14971, including 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 leading continuous-improvement activities by implementing process and product quality improvement initiatives.
Strong technical writing and interpersonal skills.

Responsibilities

Lead evaluations of returned products, product reserve sample inspections, batch records, and complaint histories and trends.
Provide engineering input 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 failure modes in Amgen products and associated components following product complaints.
Conduct failure analysis using approaches and tools such as fishbone diagrams, 5 Whys, FMEA, Fault Tree Analysis, and tolerance analysis.
Lead cross-functional ideation of design solutions to reduce complaints, assess options through testing and analysis, and develop business plans for implementation.
Generate final reports in accordance with established procedures, including data collection and statistical analysis where applicable.
Support investigation lab equipment setup, develop and deliver equipment training, develop and validate test methods, and develop equipment-use SOPs.

Benefits

Health and welfare plans for staff and eligible dependents.
Retirement and savings plan with company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.
Career development opportunities.