Product Security Officer II

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Werfen Product Privacy and Security Program is 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. This role is a trusted collaborator of the Project Teams and works with the Quality and Regulatory functions to ensure the product privacy and security posture.

Key Accountabilities

• Represent the Werfen Product Privacy and Security Office.
• Responsible for leading Product cross functional team members to complete all technical aspects of product cyber security tasks and initiatives.
• Participate in customer assurance with Quality, Regulatory, Marketing, Services, and the Affiliates. This includes Product Security communications content such as:
• Product Labeling,
• Completion of security inquiries,
• Complaint and vulnerability investigation and reports,
• Provide consistent cybersecurity and privacy guidance to Werfen and Customers.
• Represent cybersecurity and privacy in the Risk Assessment as a subject matter expert including:
  • Cyber security threat management process,
  • Continuous technical analysis and monitoring of cyber security signals.
• Responsible for supporting the project or program teams with planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates for cyber security requirements and related gaps, epics, stories, and defects.
• Support the generation of an integrated cyber security management plan that meets business objectives and is in compliance with the design control process, while maximizing resource efficiency.
• Responsible to represent cybersecurity and privacy for reviews of epics, stories and defects within PI planning activities, tech reviews, and change review board meetings (CRB) as a subject matter expert for cyber security.
• Ensures product security deliverables are completed and documented as defined within the quality management systems work instructions for product security.
• Support agile teams as a cybersecurity and privacy subject matter expert. Assist with the definition of epic and story requirements and deliverables to align with product security requirements.
• Responsible to support the project and program teams to identify, risk assess, and prioritize cyber security issues, and assist in supporting design controls to implement an appropriate solution through completion.
• Represent cyber security with the product development teams to ensure cyber security and privacy is being designed into products.
• Responsible to support program and project leads for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project and are aligned with product security deliverables and requirements.
• Responsible for assisting with contributing and reviewing cyber security product documentation
• Responsible for assisting with FDA 510K submission activities and inquiries
• Responsible for assisting in oversight activities to include management reporting

Networking/Key Relationships

• Provide technical and team leadership to one or more medium project team(s) or a program team, including cyber security consulting, and cyber security technical leadership within the program area. Drive the successful attainment of Product Security program/cyber security project related goals.
• Responsible for product security program communication for both within the product security team, project team(s) and between the team(s) and executive management.

Minimum Knowledge & Experience for the position:

• At least 10 years of cyber security experience, preferably in product development with at least 4 years successful technical leadership, cyber security coordination, or cyber security management are required
• Requires Bachelor's degree in Business, Computer Science, Computer Engineering or the equivalent combination of related training, proficiency and experience.
• Certification in cyber security e.g. (CISSP/CISM/CISA, Security +; Cisco CCNP Security) preferred.
• Certification in project or program management is desirable.
• Full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction.

Skills & Capabilities:

• Problem solving, conflict management, listening, managing and measuring work
• Quality and Regulatory experience e.g. (510K submissions)
• Knowledge of domain specific standards and approaches on privacy and product security (ISO 2700x, NIST 800 Series Special Publications)
• Knowledgeable and experience with laws and regulations on cyber security, privacy, data protection and breach notification (e.g.: FDA cyber security guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971. AAMI TIR 57; 21CFR820, SB1386, etc.)
• Experience in 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 player, self-motivated, perseverance
• Strong oral and written skills

Travel Requirements:

• 10% Travel

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com