Senior Engineer - Complaints Technical Investigations

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits

Flexible work models where possible

Job summary

Amgen is seeking a Senior Engineer - Complaints Technical Investigator to join the Complaints Technical Investigations group. You will conduct advanced investigations of product complaints, own CAPAs, and drive cross-functional design improvements to enhance patient experience and product quality.

You will interact with engineering and quality functions, perform trend analyses, and mentor staff while contributing to robust investigation plans and reports that support regulatory and safety

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

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

Skills

Root cause analysis

FMEA

Six Sigma

Data analytics

Technical writing

Leadership

Cross-functional collaboration

Education

PhD in a science field

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associate degree + 8 years experience

High school diploma + 10 years experience

Tools

Fishbone diagrams

5 Whys

Risk assessments

DFMEA/FMEA

Statistical analysis

CAPA processes

Job description

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. 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, 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.

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

What We Expect Of You

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

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.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Equal Opportunity

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.