Amgen Senior Engineer- Final Product Technologies, Development in Cambridge, Massachusetts
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 crafts a multi-disciplinary program team to build drug delivery solutions which meet user requirements from concept through commercial entry. This role will advance 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, demonstrating 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.
Oversight and delivery 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 taking on sophisticated engineering problems.
Support investment analysis for drug delivery technologies through demonstration that proposed solutions meet user needs in service product pipeline.
Strategically assist with technical analyses.
Develop, execute, and report verification methods and testing.
Communicate effectively at multiple interpersonal 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 accurate completion.
Ensure compliance to Regulatory and Quality requirements when generating design outputs and conducting technical reviews.
Build and review sophisticated computer simulations to support design & development efforts.
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.
Illustrate 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.
Master's Degree & 3 years of Engineering and/or Medical Device experience
Bachelor's Degree & 5 years of Engineering and/or Medical Device experience
Associate's degree & 10 years of Engineering and/or Medical Device experience
High school diploma/GED & 12 years of Engineering and/or Medical Device experience
6+ years experience in the development of drug delivery technologies for therapeutic products through commercial entry
Understanding and familiarity with the following:
US Quality System Regulations (21CFR820) and International Quality Management Systems (ISO 13485) for Medical Devices.
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 fast paced environment
Strong oral and written communication skills, decision making, presentation, and organization skills
Have the 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
Navigate ambiguity and provide a structured problem-solving approach
Organizational savvy and presence to build effective relationships across functions
Building or participating as a member of robust high-potential teams
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 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.
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.
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