Senior Software Quality Engineer, Product/Software Cybersecurity (Medical Device Software)

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.

How you will make an impact :

• 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.

What you will need (Required):

• 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 two (2) years of relevant work experience; or equivalent work experience based on Edwards criteria .
• Highly regulated industry experience
• Experience with software development and/or software quality in regulated environments

What else we look for (Preferred):

• 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.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $108,000 to $153,000 in tool (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.