Amgen

Senior Engineer- Final Product Technologies, Development

Employer
Amgen
Location
Cambridge, MA, US
Posted
Sep 13, 2020
Ref
R-102932
Required Education
High School or equivalent
Position Type
Full time
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. This aligns with Amgen's mission to serve patients.

This opportunity is located at our Cambridge, MA location. Come join us!

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. This person 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; additionally, utilizing a range of program tools, design characterization and verification methods, and design reviews. S/he will ensure 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 initiating 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 address 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 report technical analyses and report verification methods and testing;

Successfully interact with multiple organizational levels on project status, risks, issues, and accomplishments, and influence program outcomes. Also utilize project planning and monitoring methods to ensure efficient completion.

Review completed design work with both internal and external design partners, and ensure compliance to Regulatory and Quality requirements when generating design outputs and conducting technical reviews.

Craft and review detailed computer simulations to support design & development efforts; partner 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 alignment 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 successful experience in development of drug delivery technologies for therapeutic products through commercial entry

Solid understanding 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

Capability to advance multiple projects in a fast paced environment

Strong oral and written communication skills, decision making, presentation, and organization skills

Demonstrated ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain specialists from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations

Proficiency with leading thru ambiguity and providing a structured problem-solving approach

Organizational savvy and presence to form effective relationships across functions

Track record of building or participating as a member of high performing teams

Working knowledge of MS Office tools

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant, to patient.

Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.

Come join us!

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.