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Principal Software Quality Engineer
111 W John St Seattle, WA 98119 US
Job Description
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
- 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
- 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!