Engineer - Complaints Technical Investigator

Amgen•Thousand Oaks, CA

2d•$88,281 - $119,439

About The Position

Amgen is seeking an Engineer - Complaints Technical Investigator to join its Complaints Trending and Investigation group. The team works to continuously improve clinical and commercial drug delivery devices, support product supply, and optimize the patient experience. The role conducts forensic evaluations of complaint units for standard and advanced investigations related to product design and usability. It requires understanding how customers and patients use Amgen’s packaged or distributed products, as well as the manufacturing processes for those products. The investigator also supports root cause analysis, investigation laboratory infrastructure and equipment setup, and test method development and validation.

Requirements

Meet one of the following education and experience pathways: Master’s degree; Bachelor’s degree and 2 years of operations experience; Associate’s degree and 6 years of operations experience; or 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/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 under ISO 14971, including System Risk Analysis, User Risk Analysis, DFMEA/FMEA, and other risk management tools.
Experience writing protocols and reports, developing and executing processes and tests, and designing 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 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 failure modes for Amgen products and associated components in response to product complaints.
Perform failure analysis using methods and tools such as fishbone diagrams, 5 Whys, FMEAs, Fault Tree Analysis, and tolerance analysis; use equipment such as CT scanners, Instron tensile test machines, and SEM when applicable.
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 according to established procedures, potentially including data collection and statistical analysis.
Support investigation laboratory 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.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous 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.