The Senior Software Quality Engineer will be a critical member of the Critical Care Software Quality team. The candidate will report into Software Quality Manager and have a strong dotted line to the Product Security Senior Manager. The Product Security Senior Manager will provide the technical leadership and direction for the cybersecurity risk process related activities. The Senior Software Quality Engineer will assist the organization in executing Cybersecurity Risk Assessment activities to reduce vulnerabilities to Edwards’s product software medical devices. This position will provide opportunities for advancement within our growing organization. We are looking for an ambitious candidate with a strong technical background, excellent communication skills (comfortable presenting to all levels of seniority), and the ability to build trusting relationships within the organization.
Responsibilities for success in this position include:
Executing Cybersecurity risk analysis on our devices, and set prioritization based on Edwards processes.
Assisting in improving processes and procedures related to Cybersecurity Risk management based on industry trends.
Working in close partnership with Information Technology Cybersecurity and R&D Management to address and monitor cybersecurity risks throughout the SDLC.
Providing meaningful cybersecurity risks metrics.
Supporting requirements and testing activities based on risk analysis.
Supporting the Software Quality Assurance team in ensuring cybersecurity processes meet EW procedures and instructions.
Supporting Regulatory submissions and coordinating responses regarding cybersecurity findings.
Effectively manage priorities, multiple projects and ability to communicate at all levels of personnel.
Requirements / Preferences / Qualifications:
Must have a Bachelor’s degree in Scientific or Engineering related fields, plus (4) years of relevant experience: OR Master’s degree in Scientific or Engineering related fields, plus (3) years of relevant experience.
Requires a minimum of three (3) years of work experience in highly regulated industries (Medical Device industry preferred).
Requires a minimum of two (2) years in a cybersecurity role and/or software development.
Excellent written and verbal communication skills required.
Must have familiarity with software (IEC62304) and cybersecurity (NIST) guidelines; including understanding of Waterfall and Agile concepts in context with the SDLC process.
Knowledge and experience in Quality Systems Risk Management (ISO14971) solutions, processes, and techniques is preferred.
Internal Number: 014908
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.