Sr Manager, Engineer - Complaints Trending - Integrated Signal Management (US - Remote)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Sr Manager, Senior Engineer - Integrated Signal ManagementLive
What you will do
Lets do this. Lets 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 Amgens 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 Amgens packaged and/or distributed mechanical and/or electromechanical products
- Understand manufacturing processes for Amgens 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 safetys perspectives
- Contribute to technology and process improvement opportunities
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
- Masters degree and 6 years of related medical/biopharma development or post-market experience; OR
- Bachelors degree and 8 years of related medical/biopharma development or post-market experience; OR
- Associates degree and 10 years of related medical/biopharma development or post-market experience; OR
- 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
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.
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 requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.