Sr. Device Software Engineer
One Amgen Center Drive Thousand Oaks, California 91320 | Contract
Searching for a Senior Engineer who will be a technical hands-on professional experienced with embedded software development in 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 software development activities including requirements, design, implementation and verification for complex electromechanical 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 Senior Engineer include:
- Participate in defining software requirements
- Participate in software design
- Develop software code
- Develop test for software unit verification
- Develop test for software system verification
- Perform software unit test and software verification test and generate reports
- Perform software test tool requirement analysis, design, implementation and validation
- Work with tools for software configuration management, software build and software verification
- 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.
- 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
- Proficiency in C programming language
- Knowledge of STM8 microcontroller, gitlab, jenkins, ALM, and doors