Senior Engineer - Combination Product Operations, Risk Engineering (CPO-RE)

Career Category

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. 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 - Combination Product Operations, Risk Engineering (CPO-RE)

What you will do

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

Amgen is currently seeking a Senior Engineer in our Combination Product Operations Risk Engineering (CPO-RE) team for Risk Management. In support of Amgen’s mission to serve patients, the CPO-RE team at Amgen is a diverse team working to develop and continuously improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience.

The Sr Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMFs) for Amgen’s portfolio of products, serve as Risk Management lead on assigned projects, and support Design Control processes and activities.

The Sr Engineer will create/maintain risk assessments such as System Risk Assessments and Use Risk Assessments with close coordination with respective multi-functional teams.

The Sr Engineer will bring to bear leadership skills to actively engage with multi-functional groups to support the Risk Management File, as well as support multi-functional processes collaborating with Risk Management. This includes working with the Complaints, Safety, Human Factors, and other teams to support life cycle management.

The Sr Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing CPO-RE in corresponding audits. The Sr. Engineer will assist with the advancement of design controls activities/processes, the continued advancement of risk assessment processes, methods and tools, and business processes for ongoing continuous improvement.

Responsibilities include but are not limited to:

• Ensures Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971.

• Creates and maintains the Risk Management Files.

• Conducts risk assessments and creates/revises risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.

• Creates and maintains hazard analyses, use risk assessments, and system risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.

• Contribute to process improvement efforts for Risk Management and Design Controls.

• Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures.

• Leads periodic and event driven risk reviews of the Risk Management Files for commercialized products.

• Supports the complaints intake teams with assessment of risks related to reported complaints.

• Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements

• Successfully influences outcomes, communicates with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting.

• Understands manufacturing processes for Amgen’s packaged and/or distributed products.

• Supports root cause analysis of complaint investigations.

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering and/or Operations expe