What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Position Summary:As a Software Quality Engineer specializing in cybersecurity, you will be instrumental in ensuring the security, integrity, and compliance of software and products throughout the development lifecycle and post-market phases. The role involves implementing and maintaining cybersecurity best practices, overseeing post-market cybersecurity activities, conducting risk assessments, collaborating with cross-functional teams to enhance the overall security posture of products, and improving the cybersecurity aspects of software to meet regulatory requirements and industry standards.Responsibilities:Develop and implement a comprehensive cybersecurity strategy within the software product domain.Provide leadership and guidance in aligning post-market cybersecurity initiatives with business objectives.Lead and/or mentor a team of experienced quality assurance professionals, offering expertise and support in the implementation of cybersecurity best practices.Foster a culture of compliance, quality, continuous learning, and innovation within the team.Collaborate closely with development and security team leaders to define and maintain medical device pre- and post-market security program activities. This includes, but is not limited to, security risk planning, security architecture, threat modeling, security risk assessment, scanning, penetration testing, and vulnerability management.Ensure process compliance with relevant regulatory requirements, including, but not limited to, FDA cybersecurity guidelines, ISO 13485, IEC 62304, ISO 14971, and other applicable regulations and standards.Collaborate with Product Security, Regulatory Affairs, and Product Development to interpret and implement pre- and post-market cybersecurity-related changes in regulations.Drive continuous improvement projects to advance processes and capabilities, especially in cybersecurity and software lifecycle.Establish and maintain best practices in the context of post-market medical device software cybersecurity.Oversee the development and execution of comprehensive test plans, with a specific focus on post-market cybersecurity testing.Collaborate with software development teams to ensure continuous monitoring and improvement of post-market cybersecurity measures.Develop and oversee incident response plans for post-market cybersecurity events related to software products.Develop and communicate expectations for continuous vulnerability management, covering identification, triage, analysis, and remediation recommendations.Conduct regular risk assessments and collaborate with cross-functional teams to implement effective risk mitigation strategies in post-market phases.Work closely with cross-functional teams, including development, security, operations, quality, and regulatory, to integrate cybersecurity measures seamlessly into the development lifecycle and post-market process.Actively participate in cross-functional meetings to address post-market cybersecurity concerns and requirements.Prepare and present regular reports on the status of post-market cybersecurity measures to senior leadership.Maintain thorough documentation of post-market cybersecurity processes and procedures.Coordinate the corporate corrective and preventive action program (customer complaints, audits, recalls, field corrections, and process changes) to ensure timely follow-up, completion, and documentation of corrective actions.Establish procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third-party audits.Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Requirements: In-depth understanding of medical device regulations, FDA guidelines, and international standards related to post-market cybersecurity.Expert knowledge of product development, and specifically software development (SDLC) processes and cybersecurity, Software Engineering Best Practices Design Controls, Risk Management, Verification and ValidationSolid understanding of the application of regulations and standards (21CFR 820, IVDD/IVDR, ISO 13485, ISO 14971, IEC 62304)Extensive knowledge of best practices for medical device security across the lifecycle: SW96, TIR57, TIR97, CVSS, MITRE RubricStrong understanding of cybersecurity principles, standards, and best practicesExperience with post market activities (complaint handling/failure investigations)Experience with industry-standard security testing tools and methodologiesExcellent written and oral communication skillsRelevant certifications such as CISSP, CISM, or certifications related to medical device quality and regulatory affairs are a plus.Self-motivated, strong leadership skills with demonstrated ability to guide and influence medium sized teams effectively.Working across teams and functions, managing and escalating riskExcellent organizational skills and able to work cross-functionally.Hands-on experience with Software used in Next Generation Sequencing products preferred.Occasional travel may be required.All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Experience/Education:Bachelor's or Master’s degree in computer science, Information Security, or a related field10+ years of experience in quality or engineering in a regulated environment (FDA, ISO13485); Preferred direct experience working in in-vitro diagnostic and in the context of cybersecurity.Previous management or product development experience is required.Broad knowledge of all areas within Corporate sub-function or a function within an operation. Typically has depth of technical knowledge in function derived from experience in non-management and middle management roles.The estimated base salary range for the Sr. Manager / Sr. Staff, Software Quality (Cybersecurity) role based in the United States of America is: $136,100 - $204,100. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
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