The Principal Engineer will be responsible for leading the development and integration of the firmware subsystem for complex electromechanical drug delivery devices. As a member of a technical cross –functional team the Engineer will interface with key partners and external vendors to develop new drug delivery devices.
The Device Engineering, Electrical and Software Development department leads the development of the electrical, software, and firmware subsystems of electromechanical drug delivery devices.
Key responsibilities of the Principal Engineer include:
Design and develop firmware subsystem for drug delivery devices through generating architecture, design, interface, and source code.
Evaluate and select development tools.
Define and/or review the electronic and firmware subsystems requirements, risks, and mitigations and ensure subsystem requirements meet system requirements and applicable quality and regulatory standards.
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.
Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
Execute to project plans and schedules, providing high quality, on time, and on cost results.
Doctorate Degree and 2 years of Engineering experience.
Master's Degree and 6 years of Engineering experience
Bachelor's Degree and 8 years of Engineering experience
Associate's degree and10 years of Engineering experience
High school diploma/GED and 12 years of Engineering experience
10+ years of experience in software/firmware development.
Experience in Medical Device development life cycle and knowledge of design control.
Experience with formal testing and generating test protocol & reports
Extensive experience in microcontroller-based hardware and software designs, familiarity with various microcontroller architectures
Familiarity with lab instruments such as oscilloscope, logic analyzer, and simulators.
Strong problem solving, risk assessment, and risk management skills.
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.