Senior Engineer - Complaints Technical Investigations

Senior Engineer
- Complaints Technical Investigations

What you will do

Lets do this! Lets change the world! Amgen is currently seeking a Sr. Engineer
- Complaints Technical Investigator in our Complaints Technical Investigations 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
- Complaints Technical Investigator conducts technical investigations of Advanced complaints associated with product design and/or usability issues and conducts trend and consolidated investigations using data analytics and root cause investigation methodologies. This role understands customer/ patient use of Amgens packaged and/or distributed products, as well as manufacturing processes for these products. The Sr. Engineer
- Complaints Technical Investigator owns CAPAs 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 complaint sample evaluations, investigation plans, and personnel training.

• Lead root cause analysis to identify the failure mode for Amgens 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 FMEAs, Fault Tree Analysis, or tolerance analysis.
• 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
• Perform technical trends and consolidated investigations, including statistical assessment of data to identify trends
• Support the evaluation of returned products, product reserve sample inspections, batch records and review of complaint history and trends
• Generate final investigation 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
• Manage, coach and mentor staff
• Support functional management initiatives and objectives

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional weseekis an individual with these qualifications.

• Doctorate degree OR
• Masters degree and 2 years of operations experience OR
• Bachelors degree and 4 years of operations experience OR
• Associates degree and 8 years of operations experience OR
• High school diploma / GED and 10 years of operations experience

• Advanced Degree in 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 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

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, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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 where…