Engineer - Complaints Technical Investigator

Career Category

Engineering

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer - Complaints Technical Investigator

What you will do

Let’s do this. Let’s change the world! 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 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with the following qualifications:

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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