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Principal Software Quality Engineer

Seattle, WA 98119

Posted: 07/27/2023 Employment Type: Direct Hire Industry: Core Technologies - FTE Job Number: 27626

Job Description

Position Title: Principal Software Quality Engineer

Position Description: Protingent Staffing has an exciting direct hire Principal Software Quality Engineer opportunity with our client located in Seattle, WA.
Job Responsibilities:
  • Maintain SDLC and maintenance processes, identifying opportunities for continuous improvement; support V&V processes to ensure surgical navigation software performs according to documented requirements
  • Manage the disposition of defects, enhancements, and customer feedback utilizing software tracking tools
  • Lead development and execution of Software risk management procedures; lead teams in formalizing comprehensive risk analysis, software risk control measures, and risk assessments such as FMEAs and FTAs
  • Develop and analyze software related metrics to assess key process indicators; identify and implement corrective actions as necessary
  • Partner with the software development team in the review of software requirement specifications, software verification and validation plans, and associated reports to describe application, evaluation, testing and correction
  • Maintain effective communication with project teams on scope and requirement changes
  • Manage the maintenance of software development tool(s) including maintaining a validated state, where applicable
  • Participate in software requirement and user story definition, and in reviews to ensure rigor and testability
  • Participate in software audits as SME; monitor software quality processes for compliance, effectiveness, alignment with applicable regulatory and statutory requirements, and opportunities for improvement
  • Participate in validation projects for non-product software (eQMS, PLM, ERP, ) as needed using a risk- based approach
  • Other duties as assigned
Job Qualifications:
  • Minimum Bachelor’s degree in Engineering, Computer Science, or related discipline
  • 10+ years overall relevant experience, including 7+ years working in a highly regulated environment; software related role; quality, new product development or manufacturing highly preferred
  • Knowledge of medical device product development life cycle, including design controls, risk management, software configuration, design verification and validation
  • Strong working knowledge of IEC 62304, FDA Quality System Regulation, General Principles of Software Validation, ISO 13485, ISO 14971, and related medical device regulations
  • Understanding of software development life cycle (SDLC) and maintenance processes preferred
  • Experience in implementation and validation of FDA 21 CFR Part 11 compliant systems
  • Excellent communication, teamwork, mentoring skills; high ethical standards
Job Details:
  • Direct Hire 
  • $150,000 - $170,000

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

Meet Your Recruiter

Jeff Morgante

I have an ability to connect with engineers easily, with an engineering background myself, I can relate and communicate using the same language. I have been working in Technical staffing at Protingent since 2011. I have two dogs, Kaleb & Kayce and two cats, Mika and Shiloh. I am originally from upstate New York, but love living in the Pacific Northwest! I have a passion for cars, old and new.

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