Sr.Software Engineer

Location: Thousand Oaks, CA
Date Posted: 09-26-2018
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:
  • 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 
OR 
Master's Degree and 3 years of Engineering experience 
OR 
Bachelor's Degree and 5 years of Engineering experience 
OR 
Associate's degree and10 years of Engineering experience 
OR 
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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