Principal Engineer (Final Product Technologies Development)
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.Live
What you will do
Lets do this. Lets change the world. In this role the Development Product Engineering (DPE) Organization at Amgen is a team with varied strengths responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgens portfolio of therapeutic products.
The DPE Principal Engineer leads a multi-disciplinary team that crafts drug delivery solutions, which meet user requirements for Amgens portfolio of therapeutic products from concept through commercial entry. The Principal Engineer leads product development programs with consideration for design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate provides mentorship for concept and development stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program. S/he ensures that the team is aligned with the tasks and is carrying out deliverables per program schedules.
- Leadership of combination product development programs in different therapeutic areas, including nephrology, bone health, oncology, inflammation, and cardiovascular.
- Lead investment analysis for drug delivery technologies through demonstration that proposed solutions meet user needs in service of Amgens product pipeline.
- Lead technically and culturally complementary teams.
- Communicate optimally at multiple organizational levels on project status, staffing topics, risks, issues, and accomplishments.
- Successfully impact program outcomes.
- Review completed design work with both internal and external design partners.
- Apply project planning and monitoring methods to ensure accurate completion.
- Ensure compliance to Regulatory and Quality requirements when supervising design outputs and conducting technical reviews.
- Collaborate with the commercial engineering organization to ensure adequate sustainment and improvement of products throughout their lifecycle.
- Facilitate development of solutions to critical business issues.
- Effectively define objectives to enable accurate metrics generation and reporting.
- As part of the organization developing device platforms, ensure alignment to architecture to support variations of the platform and system deliverable packages.
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is an engineer with these qualifications.Basic Qualifications
- Doctorate Degree & 2 years of Engineering and/or Medical Device experience OR
- Master's Degree & 6 years of Engineering and/or Medical Device experience OR
- Bachelor's Degree & 8 years of Engineering and/or Medical Device experience. OR
- Associate's Degree & 10 years of Engineering and/or Medical Device experience. OR
- High School Diploma & 12 years of Engineering and/or Medical Device experience.
- M.S. or Ph. D. in Mechanical, Biomedical Engineering, Polymer Engineering or Materials Science with 5+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry
- B.S. in Mechanical, Biomedical Engineering, Polymer Engineering or Materials Science with 10+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry.
- Solid understanding and familiarity with US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485).
- Previous experience leading teams of highly skilled engineering staff.
- Strong oral and written communication skills, decision making, presentation, and organization skills
- Demonstrated ability to collaborate and converse technically with diverse partners
- Demonstrated ability to navigate ambiguity and provide a structured problem-solving approach
- Organizational savvy and presence to form effective relationships across functions
- Solid understanding of MS Office tools
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
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.
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.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.