Product Security Officer II

Overview

The Werfen Product Privacy and Security Program provides a shared service model with responsibility for cybersecurity and privacy by design, compliance, security testing and incident response. As a Werfen Product Security Officer you are responsible for cybersecurity and privacy functions for our products and act as a trusted collaborator of the project teams, working with quality and regulatory functions to ensure the product privacy and security posture.

• Represent the Werfen Product Privacy and Security Office and lead cross‑functional product team members to complete all technical aspects of product cybersecurity tasks and initiatives.
• Participate in customer assurance with quality, regulatory, marketing, services and affiliates, including product security communications such as product labeling, completion of security inquiries, and complaint and vulnerability investigation and reporting.
• Provide consistent cybersecurity and privacy guidance to Werfen and customers.
• Represent cybersecurity and privacy in the risk assessment as a subject matter expert, managing threat processes and continuous technical analysis and monitoring of cybersecurity signals.
• Work with project or program teams on planning and scheduling, clarifying scope of work, defining deliverables and estimating cybersecurity requirements, gaps, epics, stories and defects.
• Support the generation of an integrated cybersecurity management plan that meets business objectives and is compliant with the design control process while maximizing resource efficiency.
• Represent cybersecurity and privacy in PI planning activities, tech reviews and change review board meetings as a subject‑matter expert.
• Ensure product security deliverables are completed and documented per the quality management system’s work instructions.
• Support agile teams as a cybersecurity and privacy expert, assisting with definition of epic and story requirements and deliverables aligned with product security requirements.
• Collaborate with project and program teams to identify, assess and prioritize cyber security issues and risk, and support design controls to implement solutions.
• Ensure cybersecurity and privacy are designed into products through collaboration with product development teams.
• Support program and project leads to oversee vendors providing development, testing or technical services, ensuring alignment with product security deliverables and requirements.
• Contribute to and review cybersecurity product documentation, support FDA 510K submission activities and inquiries, and assist with oversight activities including management reporting.

• Provide technical and team leadership to one or more medium project or program teams, driving successful attainment of Product Security program and cyber security project goals.
• Communicate product security program information within the product security team, project teams and to executive management.

Minimum Knowledge & Experience

• At least 10 years of cybersecurity experience, with at least 4 years of successful technical leadership, cybersecurity coordination or management.
• Bachelor’s degree in business, computer science, computer engineering or a related field.
• Preferred certifications: CISSP, CISM, CISA, Security+, Cisco CCNP Security.
• Desirable: certification in project or program management.
• Full and comprehensive knowledge of the complete product lifecycle from conception to manufacturing introduction.

Skills & Capabilities

• Problem solving, conflict management, active listening and work measurement.
• Quality and regulatory experience, e.g., 510K submissions.
• Knowledge of privacy and product security standards such as ISO 27001, NIST 800 series.
• Knowledge of cyber security, privacy, data protection laws and regulations (FDA guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971, AAMI TIR 57, 21
  
  CFR
  820, SB1386).
• Experience designing or leading software products using Secure SDLC.
• Understanding of securing and hardening Windows and Linux operating systems.
• Understanding of networking and network security.
• Familiarity with agile and project management tools and techniques.
• Team…