Senior Software Quality Engineer - Cybersecurity

Edwards Lifesciences•Irvine, CA

22h

About The Position

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. The Senior Software Quality Engineer is a key member of the Software Quality organization, responsible for ensuring the cybersecurity of product software including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), software as an accessory to a medical device, and other Digital Health Technologies. This role is responsible for owning and advancing product cybersecurity processes established within our Quality Management System and ensure alignment with applicable regulatory standards and industry guidance. The position will work in close partnership with R&D, Product Security, Quality and other cross-functional team members to integrate cybersecurity requirements throughout the product software development lifecycle and support effective postmarket cybersecurity management. We are seeking an ambitious, technically strong candidate with a solid foundation in quality and cybersecurity, excellent communication skills, and the ability to build trusted relationships across the organization. This role offers meaningful opportunities to grow within a dynamic and evolving Software Quality function.

Requirements

Bachelor’s degree in Scientific, Engineering, or Computer Science fields plus four (4) years of relevant work experience; OR Master’s degree Scientific, Engineering, or Computer Science fields plus three (3) years of relevant work experience.
Highly regulated industry experience
Experience with software development and/or software quality in regulated environments

Nice To Haves

Engineering or Computer Science degree
Medical device industry experience
Experience with cybersecurity risk assessments
Experience integrating cybersecurity into the SDLC / design controls
Familiarity with vulnerability management and post market cybersecurity processes
Familiarity with software (IEC 62304) and cybersecurity (NIST) guidelines; including understanding of Waterfall and Agile concepts in context with the SDLC process.
Knowledge and experience in Medical Device Risk Management (ISO 14971)
Excellent written and verbal communication skills required.

Responsibilities

Own the establishment, implementation, and continuous improvement of cybersecurity related processes for product software established in our Quality Management System
Review and approve product cybersecurity related deliverables across the lifecycle, including planning, requirements, architecture/design, risk management, verification and validation, and problem resolution (dispositioning of cybersecurity vulnerabilities and defects).
Execute Cybersecurity risk analysis on our products.
Provide assurance that all requirements related to cybersecurity are followed when developing or making changes to product software.
Work in close partnership with Product Security, Quality and R&D to address and monitor cybersecurity risks throughout the Product Software Development Lifecycle.
Support regulatory submissions and responses regarding cybersecurity related requests.
Effectively manage multiple priorities, projects and ability to communicate at all levels of personnel.
Author, review and approve documents in our Application Lifecycle Management and Product Lifecycle Management systems.
Willingness to work in a fast-paced, dynamic environment to meet the needs of the business and deliver safe quality products to our patients.