Illumina
Sr. Software Quality Engineer (Cybersecurity)
Illumina, San Diego, California, United States, 92189
Overview
Sr. Software Quality Engineer (Cybersecurity) – Illumina Join to apply for the Sr. Software Quality Engineer (Cybersecurity) role at Illumina. The Software Quality (Cybersecurity) group is a highly specialized team within Design Quality. This role provides support to Illumina’s product security and product/software development teams to ensure compliance with cybersecurity regulations and standards, leads safety risk management activities related to cybersecurity, and supports cybersecurity activities across the product lifecycle. This is not a development or testing position. Responsibilities
Provide quality compliance support to new and sustaining product development teams focusing on cybersecurity and design control processes Lead safety risk management activities related to cybersecurity (e.g., risk assessments, hazard analysis) Support threat modeling, security risk and vulnerability assessments, and penetration testing Develop and maintain safety risk management deliverables (e.g., Risk Management Files, FMEAs) addressing cybersecurity-related risks Work with cross-functional teams to integrate cybersecurity measures into the product development lifecycle and post-market processes Assist in regulatory submissions, ensuring cybersecurity documentation aligns with FDA and other regulatory bodies Provide training to internal teams on cybersecurity compliance and safety risk management Collaborate with security and development teams to define and maintain medical device pre- and post-market security program activities Ensure process compliance with regulatory requirements, including FDA cybersecurity guidelines, ISO 13485, ISO 14971, and other applicable standards Ensure quality and completeness of design history files for the product 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 Support post-market activities related to product anomalies – Complaint Handling, Quality Investigations, CAPAs Encourage partners and stakeholders in product development to accept responsibility for product quality Education
Bachelor’s degree in Computer Science, Software Engineering, Biomedical, Cybersecurity or related discipline Requirements
Working knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices 3+ years’ experience in software quality engineering or related role in a medical device / IVD company environment Working experience with ISO 13485, ISO 14971, IEC 62304 Understanding of cybersecurity standards (AAMI SW96, TIR57, IEC 81001-5-1), risk management, and FDA regulations; experience with safety risk management (FMEAs, risk assessments) Able to deliver quality output under supervision and with general direction Ability to operate flexibly in a fast-paced environment Collaborates with Product Security, Product Development, Testing, Validation, etc. to drive a culture of Quality Strong interpersonal, verbal and written communication skills Apply Quality Engineering principles (structured development process, risk management, etc.) Quality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.) Occasional travel may be required Location & Benefits
Base salary range: $88,200 – $132,400 (USD). Compensation may vary with level, location, and market data. Eligible employees may participate in variable pay programs and may receive equity. Benefits include genomics sequencing access, health/dental/vision, retirement benefits, and paid time off. Equal Opportunity
Illumina is an equal opportunity employer. We value belonging and an inclusive environment. We prohibit discrimination based on sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, disability, genetic information, sexual orientation, pregnancy, military or veteran status, citizenship status, and other protected characteristics. Background checks are conducted for conditional offers. Reasonable accommodations are available; contact accommodations@illumina.com. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
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Sr. Software Quality Engineer (Cybersecurity) – Illumina Join to apply for the Sr. Software Quality Engineer (Cybersecurity) role at Illumina. The Software Quality (Cybersecurity) group is a highly specialized team within Design Quality. This role provides support to Illumina’s product security and product/software development teams to ensure compliance with cybersecurity regulations and standards, leads safety risk management activities related to cybersecurity, and supports cybersecurity activities across the product lifecycle. This is not a development or testing position. Responsibilities
Provide quality compliance support to new and sustaining product development teams focusing on cybersecurity and design control processes Lead safety risk management activities related to cybersecurity (e.g., risk assessments, hazard analysis) Support threat modeling, security risk and vulnerability assessments, and penetration testing Develop and maintain safety risk management deliverables (e.g., Risk Management Files, FMEAs) addressing cybersecurity-related risks Work with cross-functional teams to integrate cybersecurity measures into the product development lifecycle and post-market processes Assist in regulatory submissions, ensuring cybersecurity documentation aligns with FDA and other regulatory bodies Provide training to internal teams on cybersecurity compliance and safety risk management Collaborate with security and development teams to define and maintain medical device pre- and post-market security program activities Ensure process compliance with regulatory requirements, including FDA cybersecurity guidelines, ISO 13485, ISO 14971, and other applicable standards Ensure quality and completeness of design history files for the product 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 Support post-market activities related to product anomalies – Complaint Handling, Quality Investigations, CAPAs Encourage partners and stakeholders in product development to accept responsibility for product quality Education
Bachelor’s degree in Computer Science, Software Engineering, Biomedical, Cybersecurity or related discipline Requirements
Working knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices 3+ years’ experience in software quality engineering or related role in a medical device / IVD company environment Working experience with ISO 13485, ISO 14971, IEC 62304 Understanding of cybersecurity standards (AAMI SW96, TIR57, IEC 81001-5-1), risk management, and FDA regulations; experience with safety risk management (FMEAs, risk assessments) Able to deliver quality output under supervision and with general direction Ability to operate flexibly in a fast-paced environment Collaborates with Product Security, Product Development, Testing, Validation, etc. to drive a culture of Quality Strong interpersonal, verbal and written communication skills Apply Quality Engineering principles (structured development process, risk management, etc.) Quality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.) Occasional travel may be required Location & Benefits
Base salary range: $88,200 – $132,400 (USD). Compensation may vary with level, location, and market data. Eligible employees may participate in variable pay programs and may receive equity. Benefits include genomics sequencing access, health/dental/vision, retirement benefits, and paid time off. Equal Opportunity
Illumina is an equal opportunity employer. We value belonging and an inclusive environment. We prohibit discrimination based on sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, disability, genetic information, sexual orientation, pregnancy, military or veteran status, citizenship status, and other protected characteristics. Background checks are conducted for conditional offers. Reasonable accommodations are available; contact accommodations@illumina.com. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
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