Senior Engineer - Complaints Technical Investigations

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Sr. Engineer - Complaints Technical Investigator to conduct technical investigations of advanced complaints linked to product design and usability.

You will own CAPAs from root cause analysis, interact with engineering and quality teams, and mentor staff to improve processes and product reliability. Responsibilities include leading root cause analyses, conducting trend investigations, and generating final reports per procedures.

Qualifications

• Advanced Degree in Science (preferred)
• 10+ years of progressive and relevant experience
• 5+ years in complaints or failure analysis investigations within a development or manufacturing environment (medical devices)
• Proven experience with medical devices
• Six Sigma proficiency for root cause analysis
• ISO 14971 risk management experience (System/User DFMEA/FMEA)
• Experience with protocol and report writing, process/test development and DOE
• Experience leading continuous improvement initiatives
• Strong technical writing and interpersonal skills

Responsibilities

• Lead root cause analysis to identify the failure mode for Amgen products and components due to complaints
• Perform failure analysis using fishbone/5 Whys, FMEAs, Fault Tree Analysis, and tolerance analysis
• Lead cross-functional ideation of design solutions and assess feasibility through testing and analysis
• Perform technical trend investigations and statistical assessments to identify trends
• Support evaluation of returned products, sample inspections, batch records, and review of history/trends
• Generate final investigation reports per established procedures with data analysis
• Develop and perform relational data analytics in investigations
• Advise management on trend and process-improvement opportunities
• Provide input to engineering for product improvements
• Manage, coach and mentor staff; support functional management initiatives

Skills

Root cause analysis

Data analytics

Six Sigma

Technical writing

Interpersonal skills

Risk management

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associates degree + 8 years experience

High school diploma/GED + 10 years experience

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's 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. 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.

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.

Job Responsibilities

• 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

Basic 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 ofoperations experience

Preferred Qualifications

• 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

What you can expect from 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, 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 possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen anticipates accepting applications until August 19, 2026; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.