The Software Quality Engineer will be a critical member of the 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 cyber-security risk process related activities. The Software Quality Engineer will assist the organization in executing Cyber-security Risk Assessment activities to reduce vulnerabilities to 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 Cyber-security risk analysis on our devices, and set prioritization based on processes.
• Assisting in improving processes and procedures related to Cyber-security Risk management based on industry trends.
• Working in close partnership with Information Technology Cyber-security and R&D Management to address and monitor cyber-security risks throughout the SDLC.
• Providing meaningful cyber-security risks metrics.
• Supporting requirements and testing activities based on risk analysis.
• Supporting the Software Quality Assurance team in ensuring cyber-security processes meet EW procedures and instructions.
• Supporting Regulatory submissions and coordinating responses regarding cyber-security 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 cyber-security role and/or software development.
• Excellent written and verbal communication skills required.
• Must have familiarity with software (IEC62304) and cyber-security (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.
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Role: Software Quality Engineer - Cybersecurity - 20603
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