Senior Engineer (Final Product Technology Development)

In support of Amgen's mission to serve patients, the Final Product Development Engineering organization at Amgen is a diverse team responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgen's portfolio of therapeutic products.

The Senior Development Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for Amgen's portfolio of therapeutic products from concept through commercial entry. The Senior Development Engineer advances technical programs, contributing to definition of 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 establishes well-supported insights for concept and development stage solutions to serve user needs and the needs of the pipeline portfolio, utilizing 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.

Position Responsibilities include but are not limited to:

• Oversight and implementation of drug delivery technical assessment projects in different therapeutic areas, including nephrology, bone health, oncology, inflammation, and cardiovascular.
• Develop and exploit structured, efficient approaches to analysis and design to tackle sophisticated engineering problems.
• Support investment analysis for drug delivery technologies through demonstration that proposed solutions meet user needs in service of Amgen's product pipeline.
• Develop, execute, and chronicle technical analyses.
• Cultivate, fulfill, and report verification methods and testing.
• Communicate optimally at multiple organizational levels on project status, risks, issues, and accomplishments.
• Optimally influence program outcomes.
• Review completed design work with both internal and external design partners.
• Utilize project planning and monitoring methods to ensure accurate completion within deadlines.
• Ensure compliance to Regulatory and Quality requirements when generating 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 effective metrics generation and reporting.
• As part of the team working on device platforms, ensure adherence to architecture to support variations of the platform and system deliverable packages.

Basic Qualifications:

Doctorate Degree
OR

Master's Degree and 3 years of Engineering and/or Medical device experience
OR

Bachelor's Degree and 5 years of Engineering and/or Medical device experience
OR

Associate's degree and 10 years of Engineering and/or Medical device experience
OR

High school diploma/GED and 12 years of Engineering and/or Medical device experience

Preferred Qualifications:

• MS in Biomedical, Mechanical, Materials, Chemical Electrical, Systems Engineering or similar
• Proven success leading development of early stage medical device or drug delivery technologies
• Success in strategic review and creation of intellectual property
• 5 years in engineering of drug delivery device, primary container, packaging or medical diagnostics
• Experience in product submission for agency review and commercialization
• Familiarity with lean manufacturing and six-sigma methodology
• Strong written and verbal communication skills
• Experience in management of external design, development, and manufacturing partners
• Strong problem solving and risk management skills
• Demonstrated success with technical diligence and investment
• Familiar with appropriate international design development standards
• Experience with small scale device assembly
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Capable of working on different projects in a deadline driven environment
• Strong decision making and interpersonal skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

Join Us

If 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.