Amgen

Senior Engineer- Final Product Technologies, Development

Employer
Amgen
Location
Cambridge, MA, US
Posted
Aug 30, 2020
Ref
R-93772
Required Education
High School or equivalent
Position Type
Full time
In support of Amgen's mission to serve patients, the Development Product 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 create 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, leveraging 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.

Responsibilities include but are not limited to:
  • Oversight and execution 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 solve complex 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 report technical analyses.
  • Develop, execute, and report verification methods and testing.
  • Communicate effectively at multiple organizational levels on project status, risks, issues, and accomplishments.
  • Successfully influence program outcomes.
  • Review completed design work with both internal and external design partners.
  • Utilize project planning and monitoring methods to ensure timely completion.
  • Ensure compliance to Regulatory and Quality requirements when generating design outputs and conducting technical reviews.
  • Create and review advanced computer simulations to support design & development efforts.
  • Interface with the commercial engineering organization to ensure adequate sustainment and enhancement 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 & 3 years of Engineering and/or Medical Device experience

OR

Bachelor's Degree & 5 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/GED & 12 years of Engineering and/or Medical Device experience

Preferred Qualifications
  • 6+ years industry experience in development of drug delivery technologies for therapeutic products through commercial entry
  • Working knowledge and familiarity with the following:
    • US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485).
    • Drug-Device and Biologic-Device Combination Product Requirements for cGMP.
    • Physical test method development, qualification, and validation.ISO 14971 and ISO 11608.
    • Laboratory equipment and techniques for device development and testing.
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Strong problem-solving skills
  • Capability to advance multiple projects in a deadline-driven environment
  • Strong oral and written communication skills, decision making, presentation, and organization skills
  • Proven ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations
  • Demonstrated ability to navigate ambiguity and provide a structured problem-solving approach
  • Organizational savvy and presence to build effective relationships across functions
  • Track record of building or participating as a member of high performing teams
  • Working knowledge of MS Office tools


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.