Remote Director, Product Security - MedTech Leader
Johnson & Johnson
Job Description
Job Description
Johnson & Johnson MedTech is recruiting a Director, Product Security for the Circulatory and Restoration Business Unit and the Central Product Security Services within the Information and Risk Management (ISRM) organization. This role is open to remote candidates in the US. The position provides product security leadership for the Circulatory and Restoration business segments, and for Product Security Central Engineering Services.
The ideal candidate is a leader with Quality, Regulatory, R&D and Commercial awareness, able to simplify complex security topics to various audiences. This role leads a team of cybersecurity managers and engineers with responsibility for further developing and operating a comprehensive business unit level product security program.
Key Responsibilities
- Define and execute the Business Units product security strategy aligned with FDA/MDR/524B expectations, and QMS requirements.
- Lead and grow a global product security team, fostering collaboration that balances technical rigor with business needs.
- Oversee security integration across medical devices, software, mobile applications, embedded devices, and cloud environments.
- Partner with Regulatory, Quality, Legal, Privacy, and Commercial teams to ensure cybersecurity requirements are built into Class I, II, and III devices, supporting PMA and 510(k) submissions.
- Champion secure SDLC, DevSecOps, SBOM generation/validation, and vulnerability management across device and software platforms.
- Lead emerging technologies (AI and Quantum Cryptography) for medical devices and that will be impacted by cybersecurity. Make internal and external policy recommendations to mitigate threats and vulnerabilities.
- Lead post‑market security activities including vulnerability disclosures, CAPAs, routine cyber patching, and incident response.
- Operationalize implementation of J&J's enterprise level Product Security Quality Standards and framework throughout the MedTech portfolio of medical devices and supporting platforms.
- Act as senior product security SME with customers, hospital IT/IS staff, and clinicians, translating technical requirements into clear business and clinical impact.
- Represent product security in FDA and international regulatory inspections, reinforcing trust in our devices.
- Advance Product Security J&J enterprise Governance and Quality efforts, including J&J Quality Standards for Product Security and ISRM Product Security Framework.
- Lead product security Quality and Regulatory cyber efforts within J&J and through key industry forums (e.g., MDIC, AdvaMed, Health‑ISAC) to drive alignment and industry collaboration.
- Oversee centralized Product Security penetration testing function serving business unit product security teams to provide real‑world risk identification and remediation across MedTech product portfolios.
- Scale centralized DevSecOps function serving business unit product security teams that integrate security tooling, secure development controls, and vulnerability management processes into CI/CD pipelines and engineering workflows.
Qualifications
- Bachelor’s degree in STEM, Engineering, Computer Science, Cybersecurity or related field, or equivalent work experience.
- Strong R&D, Regulatory or Quality experience in medical devices is highly preferred.
- 15+ years of MedTech experience in Quality, R&D, engineering, product development, medical devices, or product security, with 5+ years in leadership.
- Experience with Class I, Class II, and Class III medical devices, including 510(k) and PMA submissions. Experience with medical devices and/or connected product solutions.
- Knowledge of hardware and software security, including secure screws, tamper seals, physical port blocking, enclosure access detection, secure boot and system integrity, trusted hardware, secure coding, identity and access management, PKI, integrating security into the development lifecycle (DevSecOps) and manufacturing lifecycle.
- Experience with medical device cybersecurity regulatory expectations and risk management framework, including FDA cybersecurity guidance, section 524B of the FD&C Act for cyber devices, ISO/IEC 81001‑5‑1, NIST CSF, NIST 800‑175, FIPS 140‑3, and IEC 62443 and global frameworks.
- Demonstrated success bridging Engineering, Quality, Regulatory, Legal, Privacy, and Commercial functions.
- Certifications (nice to have): CISSP, CSSLP, CISM, CISA, or equivalent.
Required Skills
- Hardware Security
- Medical Device Security
- Product Security
- Software Security
Preferred Skills
- Leadership experience in cybersecurity or product security within MedTech.
- In‑depth knowledge of FDA 524B and related regulatory frameworks.
- Experience with AI and Quantum Cryptography in medical devices.
Salary
The anticipated base pay range for this position is $150,000.00 - $258,750.00.
Benefits
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington)
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52‑week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time‑Off – 80 hours per calendar year
EEO and Accessibility Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants may contact us via https://www.jnj.com/contact-us/careers; internal employees may contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr