Sr. Software Quality Engineer (Cybersecurity)

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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 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:

· 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. Should the level or location of the role change during the hiring process, the applicable base pay