Manager of Product Cybersecurity; Hybrid, Boston

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

We are seeking a Manager of Product Cybersecurity to lead and execute cybersecurity strategy for medical devices and Software as a Medical Device (SaMD) across the full product lifecycle. This role is critical to ensuring the safety, effectiveness, and regulatory compliance of connected healthcare products while enabling innovation and speed to market.

This is a player coach role: you will directly contribute to threat modeling, design reviews, vulnerability management, and regulatory submissions while leading and mentoring a small team of product security engineers.

• Lead and personally execute cybersecurity activities across the product lifecycle, from concept through postmarket support.
• Perform and review:
  • Threat modeling and attack surface analysis
  • Secure architecture and design reviews
  • Security requirements definition and verification
• Manage and approve third-party penetration testing.
• Partner with R&D to embed securebydesign practices into hardware, firmware, software, cloud, and mobile components.
• Guide secure development aligned with IEC 62304, ISO 14971, ISO 270001, and other regulatory cybersecurity expectations.
• Integrate cybersecurity into design controls, software lifecycle processes, and system engineering practices.

• Lead the product vulnerability management program, including:
  • Vulnerability intake, triage, and risk assessment
  • Coordinated disclosure and remediation
  • CVE tracking and SBOM-driven analysis
• Guide product cybersecurity incident response, including root cause analysis and corrective actions.
• Support efforts to ensure monthly security testing is running successfully across products through support integration of security tools through automation.

• Lead cybersecurity contributions for:
  • FDA submissions (U.S.)
  • EU MDR technical documentation
  • Other international markets as required
• Author and/or review cybersecurity documentation, including:
  • Threat models and risk assessments
  • Cybersecurity sections of regulatory submissions
  • Security architecture and design artifacts
• Ensure alignment with:
  • FDA Cybersecurity Guidance
  • EU MDR and IEC 8100151
  • ISO 14971 and IEC 62304
  • NIST Cybersecurity Framework and relevant global standards

• Lead, mentor, and grow a team of product cybersecurity engineers.
• Balance hands‑on technical work with prioritization, planning, and delivery.
• Establish clear pragmatic cybersecurity processes, metrics, and accountability across product teams.

• Bachelor's degree in Computer Science, Engineering, Cybersecurity, or related field.
• 8+ years of cybersecurity experience, with direct experience securing medical devices or SaMD.
• 3+ years of experience leading or mentoring cybersecurity or product security teams.
• Strong hands‑on experience with:
  • Secure software development
  • Embedded and/or cloud‑connected medical devices
• Threat modeling and risk analysis.
• Experience in healthcare and regulatory environments.

• Experience supporting FDA submissions and regulatory audits.
• Familiarity with SBOM standards (e.g., SPDX, Cyclone
  
  DX).
• Knowledge of cloud security for regulated healthcare environments.
• Familiarity with US Department of Defense (DoD) Authorization to Operate (ATO).
• Relevant certifications (e.g., CISSP, CSSLP, HCISPP).

• Overall product cybersecurity program is easy to understand and execute.
• Products ship securely, compliantly, and on time without last‑minute cybersecurity surprises.
• Cybersecurity risks are clearly understood, documented, and mitigated throughout the product lifecycle.
• Engineering teams proactively integrate security into design and development.
• Regulators and auditors view cybersecurity practices as mature, transparent, and well‑governed.

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