Sr Engineer - Technical Investigator
BioSpace
Thousand Oaks, CA
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Engineer - Technical Investigator What You Will Do Lets do this! Lets change the world! Amgen is currently seeking a Sr. Engineer in our Complaints Trending and Investigation group. In support of Amgens 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 Sr. Engineer - Technical Investigator conducts technical investigations, including root cause analysis, for complaints associated with product design and/ or usability issues and conducts trend and consolidated investigations using data analytics. This role understands customer/ patient use of Amgens packaged and/or distributed products, as well as manufacturing processes for these products. The Sr. Engineer owns CAPAs to support identifying design solutions based on root cause and will also participate in multi-functional ideation of design solutions. Also maintains close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities also include evaluation of returned product using equipment such as CT scanners, support with investigation lab infrastructure, equipment setup, personnel training and method development and validation. Job Responsibilities
- Lead root cause analysis to identify the failure mode for Amgens products and associated components due to product complaint
- Perform failure analysis using tools and processes to identify root cause using tools such as tolerance analysis, fishbone diagrams, 5 Whys, and risk assessments such as FMEAs or Fault Tree Analysis. Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines 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
- Lead technical trend and consolidated investigations, including statistical assessment of data to identify cause of trends
- Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
- Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
- Develop and perform relational data analytics in support of investigations
- Advise management for trend and failure investigation process improvement
- Provide input to engineering for product improvements
- Coach and mentoring to junior engineers
- Support functional management initiatives and objectives
- Lead investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.
- High school diploma / GED and 10 years of medical/biopharma development, engineering or postmarket experience OR
- Associates degree and 8 years of medical/biopharma development, engineering or postmarket experience OR
- Bachelors degree and 4 years of medical/biopharma development, engineering or postmarket experience OR
- Masters degree and 2 years of medical/biopharma development, engineering or postmarket experience OR
- Doctorate degree
- Masters Degree in Engineering or Science
- 10+ years of progressive and relevant experience
- 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
- Proven experience with mechanical and/or electromechanical 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
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Posted 2025-10-27
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