Amgen Senior Engineer, Drug Delivery Devices in Thousand Oaks, California
Amgen is searching for a Senior Engineer who will be a technical hands-on professional experienced with embedded systems and electronic & software development in drug delivery medical devices. The Senior Engineer will be based in Thousand Oaks and will report to the Director of Device Engineering, Electrical and Software Development. The Senior Engineer will be proficient in medical device development life cycle and design guidance requirements. The senior engineer will participate in electronic and firmware/software development activities including requirements, design, implementation and verification for complex electromechanical drug delivery devices. The qualified candidate will be part of a technical team to ensure successful development of these electromechanical medical devices and will work closely with a cross-functional team as well as external vendors to develop detailed requirements, engineering specifications, verification, validation, and 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.
Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
Participate in project planning & creation of schedules
Participate in requirements, risks management reviews, and ensure subsystem requirements meet system requirements and applicable quality and regulatory standards.
Software & electrical subsystem design and implementation
Work with tools for software development, configuration management, build and verification
Execute to project plans and schedules, providing high quality, on time, and on cost results.
Integrate firmware and electronics subsystems and manage interfaces and dependencies across the system.
Perform characterization tests and generate reports.
Participate in identifying test strategy and generating detailed test protocols. Perform formal verification and generate reports.
Master's Degree & 3 years of Engineering experience
Bachelor's Degree & 5 years of Engineering experience
Associate's degree & 10 years of Engineering experience
High school diploma/GED & 12 years of Engineering experience
M.S./B.S. degree in Electrical or Computer Engineering
7+ years of experience with engineering processes and procedures
5+ years of experience in Medical Device/Combination Product development life cycle and knowledge of design control
Experience in NPI and product transfer to manufacturing
Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submission processes
Experience with external design, development, and manufacturing partners
Experience with schematic capture and PCB layout tools such as Altium or OrCAD
Proficient in C programming language
Familiarity with lean manufacturing and six-sigma methodology
Experience with material & test specs generation, protocol & report writing, risk analysis, process & test development, prototyping, design verification, validation (IQ, OQ, PQ), FMEA
Small scale device assembly experience
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 lab instruments such as oscilloscope, logic & spectrum analyzer, and battery testing equipment
Familiarity with software development environments such as IAR for STM8
Familiarity for software configuration management tools and issue tracking software such as Gitlab
Experience with battery selection and evaluation.
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
Strong oral and written communication skills, decision making, presentation and organization skills
Strong interpersonal and leadership skills
Strong problem solving, risk assessment, and risk management
Knowledge of Microsoft suite including Microsoft Project
Project management experience including estimating and forecasting
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.