Job Description - ABOJP00024787 - Engineer - Degreed IV_SJM in Plano
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ABOJP00024787 - Engineer - Degreed IV_SJM

Ref: US_EN_6_971662_1457282

Posted on 26 July 2022
  • Know the fundamental of programming.
  • Test/quality experience and/or technical writing is a plus.
  • Hands-on production equipment experience is a plus.
  • Experience in Software Validation
  • Software Testing experience
  • Contribute to design reviews, risk analyses, and document reviews
  • Software scoping and Part 11 audits.
  • Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
  • Create and execute or direct software validation protocols traceable to system/software requirements
  • Medical Device software experience, knowledge of design controls, risk management.
  • Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
  • Execute and support on-time completion of Design Control Deliverables
  • Support Design Verification and Validation planning & execution, including active cross- functional root-cause analysis investigation & resolution activities
  • Performs Software Configuration Management tasks
  • Experience with systems engineering, system requirements management, and system level risk management strategies
  • Design and perform acceptance testing on ATE systems and Non-Product Software
  • Strong foundation in computer science, with strong competencies in data structures, algorithms, and software design
  • Capable of deep-dives into code
  • Experience with SW development languages like Python, C, C++, C#, LABVIEW etc.
  • Experience with ATE and Non- Product Software validation.
  • Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
  • Bachelors’ degree, or advance degree in Computer Science, Computer Engineering or Electrical Engineering
  • 7-9 years’ experience
  • Equal Opportunity Employer/Veterans/Disabled

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