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Sr.Software Engineer

Thousand Oaks, CA
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.
  • Senior Engineer will be a technical hands-on professional experienced with embedded software development in medical devices.
  • 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.
Basic Qualifications
Doctorate Degree
Master's Degree and 3 years of Engineering experience
Bachelor's Degree and 5 years of Engineering experience
Associate's degree and10 years of Engineering experience
High school diploma/GED and 12 years of Engineering experience

Preferred Qualifications
  • 5+ 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
"This posting is for Contingent Worker, not an FTE"
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