Job Description

Product & Platform Security Architecture

  • Define cybersecurity architecture for scientific instruments, embedded systems, and connected applications across Android, Debian, Java/C++, and Eclipse RCP platforms.

  • Design secure architectures for desktop analysis applications (Java-based, Swing, RCP, and modern web-stack front ends).

  • Architect secure cloud infrastructure andapplicationsin AWS, aligning with AWS Well-Architected Framework and healthcare/clinical data protection requirements.

  • Establish threat models and security controls for interconnected lab ecosystems(support for lab of the future), including ingestion pipelines, assay workflows, and instrument-to-cloud communication.

    • Regulatory & Standards Compliance (Dx + Global)

  • Lead cybersecurity compliance strategy for regulated diagnostic products, ensuring alignment with: 
  • FDA Premarket Cybersecurity Guidance & 21 CFR 820
  • IVDR Annex I and MDCG cybersecurity expectations
  • NMPA cybersecurity and data protection requirements

  • EU Cyber Resilience Act (CRA) obligations

  • SBOM/Software Lifecycle requirements (FDA, CRA)

  • Support RUO, Clinical Laboratory, and LDT workflows withappropriate risk-basedsecurity controls.

  • Ensure alignment with global standards: ISO 14971, 13485, 27001/27002, 62304, 81001-5-1, UL 2900, and OWASP MAS/ASVS.

    • Secure Software Development Lifecycle (SSDLC)

  • Define andmaintainsecure coding and review practices for Java, C++, Python, and front-end frameworks.

  • Lead integration of StaticApplicationSecurityTesting, SoftwareCompositionAnalysis,IaCscanning, container security, and SBOM generation into CI/CD pipelines.

  • Guide engineering teams on secure-by-design patterns, secret management, secure comms, and secure data flows.

    • Threat Modeling, Risk Assessment & Vulnerability Management

  • Own threat modeling (STRIDE, attack trees, misuse cases) for instrument firmware, embedded OS, desktop clients, and cloud services.

  • Define vulnerability management processes acrosson-premiseand cloud deployments.

  • Ensure secure configuration baselines for Android and Debian-based instruments.

  • Partner with product security teams to evaluate zero-day impact, develop mitigations, and coordinate disclosures whererequired.

    • Cloud, Connectivity & Data Protection

  • Architect secure connectivity between instruments, desktop clients, and cloud systems, including TLS, mutual authentication, key rotation, and certificate management.

  • Oversee data privacy and protection controls (PII, PHI, genomic and assay-derived data) in compliance with HIPAA, GDPR, and global equivalents.

  • Ensure secure API design, identity & access management, least privilege-based role models, and zero-trust principles in AWS.

    • Cross-Functional Leadership

  • Collaborate with system architects, R&D teams, product owners,CIS,and regulatory/quality teams to ensure all products meet security and regulatory expectations.

  • Provide cybersecurity requirements into PRDs, system architecture, and risk files.

  • Serve as the technical lead during regulatory submissions and audits (FDA, EU Notified Bodies, NMPA).

  • Champion security culture through training, secure design reviews, andbest-practiceguidance.

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