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:The Software Quality (Cybersecurity) group is a highly specialized group within Design Quality. The Sr. Software Quality Engineer provides support to Illumina’s product security and product/software development teams to ensure compliance with cybersecurity regulations, lead safety risk management activities related to cybersecurity, and support cybersecurity activities across the product lifecycle.Please note that this is not a testing position.Position Responsibilities:Provide quality compliance support to new and sustaining product development teams focusing on cybersecurity and design control processesCollaborate with cross-functional teams to integrate cybersecurity into product development and maintain complianceLead safety risk management activities related to cybersecurity (e.g., risk assessments, hazard analyses)Support threat modeling, security risk and vulnerability assessments, and penetration testingAssist in incorporating security risks into the safety risk management processDevelop and maintain safety risk management deliverables (e.g., Risk Management Files, FMEAs) addressing cybersecurity-related risksWork closely with cross-functional teams, including development, security, operations, quality, and regulatory, to integrate cybersecurity measures seamlessly into the development lifecycle and post-market processAssist in regulatory submissions, ensuring cybersecurity documentation aligns with FDA and other regulatory bodiesProvide training to internal teams on cybersecurity compliance and safety risk managementCollaborate closely with security and development team to define and maintain medical device pre- and post-market security program activitiesEnsure 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 standardsCollaborate with Product Security, Regulatory Affairs, and Product Development to interpret and implement pre- and post-market cybersecurity-related changes in regulationsEnsure quality and completeness of design history files for the productParticipate in strategic/technical discussions and risk-based decision makingSupport post market activities related to product anomalies - Complaint Handling, Quality Investigations, CAPAsEncourage partners and stakeholders in product development to accept responsibility and accountability to product qualityAll listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Position Requirements:Bachelor’s Degree in Computer Science, Software Engineering, Biomedical, Cybersecurity or related disciplineWorking knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best PracticesMinimum 5 years’ experience in (software) quality engineering or related role in a medical device / IVD company environmentWorking experience with relevant industry standards (ISO 13485, ISO 14971, IEC 62304)Good understanding of cybersecurity standards (AAMI SW96, IEC 81001-5-1), risk management, and FDA regulations; experience with safety risk management (FMEAs, risk assessments)Able to deliver quality output under some supervision and with general directionAbility to operate flexibly in a fast-paced environmentPartners with other functions (Product Security, Product Development, Testing, Validation, etc.) to drive a culture of QualityGood interpersonal, verbal and written communication skillsApply Quality Engineering principles (structured development process, risk management, etc.) effectivelyQuality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.)Occasional travel may be requiredIllumina believes that everyone has the ability to make an impact, and 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.
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