Sr. Device Software Engineer

Location: Thousand Oaks, CA
Date Posted: 12-29-2017
Day to Day Responsibilities:     
  • Participate in firmware and process development for combination products.
  • Responsibilities include authoring software documentation, implementing software, test, integration, and formal verification.
Summary:
Amgen is 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.

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.

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.
Preferred Qualifications
  • 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
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