The Senior Engineer will be responsible for development and integration of the electrical and firmware subsystems for complex electromechanical drug delivery devices. The Engineer will be a member of a technical cross –functional team and will interface with key partners and external vendors to develop new drug delivery devices. The Engineer will be responsible for developing detailed requirements, engineering specifications, verification & validation, and supporting regulatory submissions of these devices.
The Device Engineering, Electrical and Software Development department leads the development of the electrical, software, and firmware subsystems of electromechanical drug delivery devices.
Travel: International and domestic travel of up to 25% might be essential.
Key responsibilities for the Senior Electrical Engineer include:
Define and/or review the electronic subsystem requirements, risks, and mitigations and ensure subsystem requirements meet system requirements and applicable quality and regulatory standards.
Design and develop electronic subsystem through generating schematics, PCB layouts, circuit simulation, characterization, and specifications.
Integrate the firmware and electronics subsystems and manage interfaces and dependencies across the system.
Identify test strategy and generate detailed test protocols. Perform formal verification and generate reports.
Work with human factors to ensure successful validation.
Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
Work with manufacturing and external vendors to transfer the design.
Master's Degree & 3 years of Electrical or Computer Engineering experience
Bachelor's Degree & 5 years of Electrical or Computer Engineering experience
Associate's degree & 10 years of Electrical or Computer Engineering experience
High school diploma/GED & 12 years of Electrical or Computer Engineering experience
5+ years of experience in Medical Device/Combination Product development life cycle and knowledge of design control
Experience with schematic capture and PCB layout tools such as Altium or OrCAD
Experience in multilayers mixed signal PCB designs and EMI mitigation
Strong hands-on skill on prototyping, board bring-up and troubleshooting down to component level
Experience in microcontroller-based hardware and software designs, familiarity with various microcontroller architectures
Familiarity with lab instruments such as oscilloscope, logic analyzer, and battery testing equipment
Familiar with the following standards: Quality System Regulation – 21CFR820, Quality Management – ISO 13485, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive, 93/42/EEC, Medical Electrical Equipment – EN 6060, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use
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.