Principal Software Quality Engineer

  • Full-time
  • Engineering
  • Senior

Job summary

Reporting to the Engineering Manager, the Principle Software Quality Engineer will provide quality leadership in the testing of software throughout the product development lifecycle of medical devices. This position will take ownership of projects, develop and coordinate Verification & Validation plans, work from requirements to create test cases, and execute the tests per project schedule. The ideal candidate will be a subject matter expert on requirements gathering, facilitating software risk assessments, defining, and implementing test strategies, guiding project teams on design control and defect analysis in accordance with industry standards and regulations.


The role

  • Establish test methodologies and acceptance criteria, execution of test protocols, data analysis, investigation, and writing final reports
  • Analyze system requirements and develop a risk-based approach to testing.
  • Refine requirements as needed working with various requirements management tools leading to generation of complete trace matrices (i.e. Doors, Jama, Helix ALM, DOORS, etc.)
  • Partner with engineering team to document and refine requirements
  • Knowledge of statistical techniques for experimental design and data analysis.
  • Good technical writing skills, including development of test methods, protocols, reports.
  • Facilitate documentation and tracking of verification activities
  • Assess and evaluate new tools and testing methodologies
  • Generate defect reports in defect tracking system and verification of correct technical fixes using such systems as Jira, ClearQuest, Helix ALM, etc.
  • Perform regression analysis/testing and associated documentation on software release changes
  • Demonstrate understanding of complete software development lifecycle phases
  • Experience in a team oriented traditional waterfall or fast-paced agile development processes, working closely with developers during feature development and testing phases
  • Support risk management activities to ensure software risk control measures are identified and verified
  • Develop and implement quality metrics associated with software development and performance

Qualifications

  • Bachelor’s degree in relevant engineering discipline or equivalent experience. BS with a Computer Science concentration, preferred. MS preferred
  • Minimum of ten (10) years’ experience with relevant and recent experience performing the same or similar type of work as required by the position in compliance with the recognized standards below.
  • Class 3 medical device verification and validation experience or equivalent
  • Strong working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971
  • Experience with defect tracking and metrics
  • Experience using automated testing tools for continuous integration
  • Experience with requirements management software such as Helix ALM, Jama or Doors
  • Proficient computer skills with applicable software packages (e.g. Microsoft Office, Matlab, Excel, etc.)