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Sr Engr, R&D

Irvine, CA 92614

Posted: 11/22/2023 Employment Type: Contract Job Category: Engineering Job Number: 593328 Is job remote?: Yes Country: United States

Job Description

Key Responsibilities:
  • Lead cross functional discussions such as Software Change Control Meetings.
  • Lead as a Software Quality team member for SaMD and SiMD projects.
  • Lead and conduct Risk Management activities including authoring of Software Hazard Analysis.
  • Lead software configuration management activities per established processes.
  • Present risk documentation in design and technical review meetings as well as review and approve software and algorithm design control documentation.
  • Collaborate with stakeholders on new and legacy quality procedure improvements based on new regulations.
  • Correct and improve build and release procedures to ensure software integrity and reduce execution time.
  • Investigate, recommend, procure, configure and maintain software development tools, as well as identifying and implementing improvements to our current tools.
  • Work in close partnership with software development teams to establish the file structure of the project Source Control libraries. You will also have responsibility for administering the Source Control tool providing maintenance and troubleshooting. We will ask you to ensure all project source materials are maintained in the Source Control library including software source code and project documentation.
  • Perform standard and exceptional software releases and project documentation releases per documented processes and best practices.
  • Responsibility for ensuring appropriateness and thoroughness in the creation, implementation, and maintenance the software release management process for multiple software applications.
  • Ensure compliance with department and company procedures.
  • Willing to work in a dynamic environment to meet the needs of the business.
  • Support internal/external/DHF audits and inspections.
  • Train, coach, and guide lower level employees on routine procedures and processes
  • Other Incidental duties

Required Education and Qualifications:
  • Bachelor's Degree in Engineering, Computer Engineering, Computer Science, Scientific, or related fields with at least 4 years of relevant experience: OR Master's Degree in same disciplines with at least 3 years of relevant experience
  • Experience working within Software Quality or Software Development or V&V (Verification and Validation) with software configuration management (SCM)
  • Strong knowledge of configuration management industry standards and best practices.
  • Experience on a variety of SCM toolsets.
  • Experience in specifying and implementing SCM solution with IT to support distributed software teams
  • Expert knowledge of the underlying concepts of Branching, Merging, and Archiving documentation and software throughout the development lifecycle
  • Experience developing guidance documentation and work instructions for enterprise use of SCM tools.
  • Significant experience and success in development of scripts and applications to facilitate automation of software releases.
  • Expert in analyzing and interpreting build results to report, communicate, and work through issues with software engineers.
  • Experience creating application specific release documentation and ensure dependencies and compatibilities through appropriate verification.
  • Solution orientated, generates multiple innovative solutions.
  • Knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11

Preferred Qualifications & Additional Skills:
  • Medical Device industry experience
  • Proven expertise in usage of MS Office Suite and PLM/ALM tools
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software
  • Substantial knowledge of business acumen products and software technologies
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