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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

 Sr Manager, Senior Engineer - Integrated Signal Management

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will report to our Director of Integrated Signal Management. The Integrated Signal Management group within Global Patient Safety is responsible for the direction and strategy for the product safety signal detection and quality complaints trending program. In support of Amgen’s mission to serve patients, it drives the definition and implementation of innovation and standard methodologies for safety data mining, signal detection management, product complaints trending, and integrated product surveillance activities.

• Manage team of engineers responsible for performing product complaints statistical excursion trending deep dives
• Understand customer / patient use of Amgen’s packaged and/or distributed mechanical and/or electromechanical products
• Understand manufacturing processes for Amgen’s packaged and/or distributed products.
• Maintain close interaction with multiple functions including Quality (e.g. complaints, device quality, product quality, external supplier quality, manufacturing quality, quality engineering) and contribute to product / device design improvements
• Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety’s perspectives
• Contribute to technology and process improvement opportunities

Win

What we expect of you

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

Basic Qualifications

• Doctorate degree and 2 years of related medical/biopharma development or post-market experience OR
• Master’s degree and 6 years of related medical/biopharma development or post-market experience; OR
• Bachelor’s degree and 8 years of related medical/biopharma development or post-market experience; OR
• Associate’s degree and 10 years of related medical/biopharma development or post-market experience; OR

Preferred Qualifications

• Degree in Engineering, Science or BioMedical;
• 5+ years of quality and/or manufacturing experience as an engineer in biotech or pharmaceutical industry
• 3+years of experience in complaints or complaints trending within a development, manufacturing or post-market environment, working with medical devices or combination products, ideally Class II and Class III
• Proven experience with mechanical and/or electromechanical medical devices
• Experience managing direct reports

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com