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.
- 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.
- Facilitate development of solutions to critical business issues; effectively define objectives to enable effective metrics generation and reporting.
- 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.
- 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.
- 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.
- Oversight and initiating of drug delivery technical assessment projects in different therapeutic areas, including nephrology, bone health, oncology, inflammation, and cardiovascular.
- ISO 14971 and ISO 11608.
- Laboratory equipment and techniques for device development and testing.
- Drug-Device and Biologic-Device Combination Product Requirements for cGMP.
- US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485).
- Physical test method development, qualification, and validation.
Qualification & Experience:
- Bachelor’s Degree & 5 years of Engineering and/or Medical Device experience
- Doctorate Degree
- High school diploma/GED & 12 years of Engineering and/or Medical Device experience
- Master’s Degree & 3 years of Engineering and/or Medical Device experience
- Associate’s degree & 10 years of Engineering and/or Medical Device experience
Vacancy Type: Full Time
Job Functions: Engineering
Job Location: Cambridge, MA
Application Deadline: N/A