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Instrumentation Laboratory - Bedford Product Security Officer in Bedford, Massachusetts


Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position 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. The role teams on Werfen Projects to ensure the product privacy and security posture. This role is a trusted collaborator of the Project Teams and work closely with Quality and Regulatory functions.

Key Accountabilities include but are not limited to:

  • 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.

  • Represent cyber security with the product development teams to ensure cyber security and privacy is being designed into products.

  • 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.

  • Participate in customer assurance. This includes Product Security communications content such as:

  • Product Labeling

  • completion of security inquirie

  • complaint and vulnerability reports

  • provide consistent cybersecurity and privacy guidance to Werfen and Customer

Min Knowledge & Experience required for the position:

  • 5-10 years of Cybersecurity and Privacy Compliance

  • 5 years’ experience leading product cyber security projects and risk management activities – in medical device or healthcare domain.

  • Experience in cross-functional cyber security activities including Product Defense in Depth, security technology, regulatory compliance and incident response

  • 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 (e.g.: Agile).

  • Thorough Understanding of securing and hardening Windows and Linux operating systems

  • Thorough understanding of networking and network security

  • Requires Bachelor’s degree in Business, Computer Science, Computer Engineering or the equivalent combination of related training, proficiency and experience. MBA or Master’s degree preferred.

  • Cyber security training and certification such as CISSP/CISM/CISA, Security +; Cisco CCNP Security.

International Mobility:

  • Required: No

Travel Requirements:

  • Minimal domestic and international travel required (<20% time)

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

Job ID: 2021-4742

Shift: 1st

External Company URL:

Street: 180 Hartwell Road