Search Jobs

Principal Software Quality Engineer

Seattle, WA 98119

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

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 been working in technical staffing since 2010, specializing in recruiting hardware, software, electrical, and mechanical engineers. My recruiting style is personal, where I understand the technology and can communicate with engineers on all levels with an engineering background myself, I can relate and communicate using the same language.

Finding an excellent fit for engineers is why I love recruiting; I can help you achieve your career goals and job transitions and find the perfect fit for you. My philosophy is “never give up”. Outside of work, I like to put my energy into listening to vinyl records, hiking, and cooking.  I have two dogs, Kaleb and Kayce, and two cats, Mika and Shiloh. I am originally from upstate New York, but I love living in the Pacific Northwest! I have a passion for cars, old and new, so finding common ground is easy for me. Let’s get started today! 

 

 

 

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Seattle, WA

Join us in the vibrant job market around Seattle, Washington! Nestled in the heart of the Pacific Northwest, this bustling city offers a perfect blend of career opportunities and outdoor adventures. With iconic landmarks like the Space Needle and Pike Place Market, world-renowned art galleries such as the Seattle Art Museum, and a thriving theater scene at venues like The 5th Avenue Theatre, Seattle is a cultural hub waiting to be explored. Not to mention the unbeatable dining scene with fresh seafood and artisanal coffee. Consider Seattle for your next career move and discover why this city is a magnet for talent and innovation. Browse our job listings today and unlock your potential in this dynamic region!