Illumina
Sr. Software Quality Engineer (Cybersecurity)
Illumina, San Diego, California, United States, 92189
Software Quality (Cybersecurity) Engineer
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. 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 and standards, leads safety risk management activities related to cybersecurity, and support cybersecurity activities across the product lifecycle. This is not a development or testing position. Tasks and responsibilities include: 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 closely with cross-functional teams, including development, security, operations, quality, and regulatory, to integrate cybersecurity measures seamlessly into the product development lifecycle and post-market process 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 closely with the security and development team to define and maintain medical device pre- and post-market security program activities Ensure process compliance with relevant regulatory requirements, including, but not limited to, FDA cybersecurity guidelines, ISO 13485, ISO 14971, and other applicable regulations and standards Ensure quality and completeness of design history files for the product 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 Support post-market activities related to product anomalies - Complaint Handling, Quality Investigations, CAPAs Encourage partners and stakeholders in product development to accept responsibility and accountability to product quality All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. 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 relevant industry standards (ISO 13485, ISO 14971, IEC 62304) Good 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 Partners with other functions (Product Security, Product Development, Testing, Validation, etc.) to drive a culture of Quality Good interpersonal, verbal and written communication skills Apply Quality Engineering principles (structured development process, risk management, etc.) effectively Quality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.) Occasional travel may be required The estimated base salary range for the Sr. Software Quality Engineer (Cybersecurity) role based in the United States of America is: $88,200 - $132,400. 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. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. 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.
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. 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 and standards, leads safety risk management activities related to cybersecurity, and support cybersecurity activities across the product lifecycle. This is not a development or testing position. Tasks and responsibilities include: 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 closely with cross-functional teams, including development, security, operations, quality, and regulatory, to integrate cybersecurity measures seamlessly into the product development lifecycle and post-market process 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 closely with the security and development team to define and maintain medical device pre- and post-market security program activities Ensure process compliance with relevant regulatory requirements, including, but not limited to, FDA cybersecurity guidelines, ISO 13485, ISO 14971, and other applicable regulations and standards Ensure quality and completeness of design history files for the product 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 Support post-market activities related to product anomalies - Complaint Handling, Quality Investigations, CAPAs Encourage partners and stakeholders in product development to accept responsibility and accountability to product quality All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. 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 relevant industry standards (ISO 13485, ISO 14971, IEC 62304) Good 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 Partners with other functions (Product Security, Product Development, Testing, Validation, etc.) to drive a culture of Quality Good interpersonal, verbal and written communication skills Apply Quality Engineering principles (structured development process, risk management, etc.) effectively Quality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.) Occasional travel may be required The estimated base salary range for the Sr. Software Quality Engineer (Cybersecurity) role based in the United States of America is: $88,200 - $132,400. 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. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. 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.