Job Title: Principal Cybersecurity Consultant - Medical DEVICES Experience
Location: Marlborough, MA
Duration: Long term Contract
Mode of Work: Fully ONSITE
Relocation mandatory if non local
I am also including the Job Description below:
Job Description:
KEY RESPONSIBILITIES
Regulatory and Notified Body support
Prepare and substantiate cybersecurity responses to FDA, DEKRA and other regulatory or conformity-assessment inquiries, findings and observations.
Review questions, identify technical and documentary evidence, support audits and regulatory meetings, and track commitments through closure.
Customer cybersecurity support
Respond to customer and partner questionnaires, assessments and security inquiries in coordination with relevant stakeholders.
Provide evidence on product and software security, vulnerabilities, risk controls and approved cybersecurity practices; keep responses consistent with product records.
Pre-launch product cybersecurity
Execute established threat modeling, risk assessments, vulnerability assessments and security testing for devices, software, connectivity and supporting systems.
Review security requirements, designs and verification evidence; prepare documentation for submissions and launch readiness.
Drive assessment, mitigation and closure of security findings with engineering and product-development teams.
Post-launch product cybersecurity
Monitor and assess emerging vulnerabilities, reported security events and product cybersecurity concerns; recommend remediation, mitigation or monitoring actions.
Assess cybersecurity impact from software updates, patches, product changes and other modifications, and maintain post-market evidence.
Provide cybersecurity input to CAPA, complaints, change control and risk-management activities when needed.
IT and connected-environment cybersecurity
Evaluate cyber risks, controls, vulnerabilities and remediation across relevant IT systems supporting medical-device development, manufacturing, testing, deployment and support.
Collaborate with IT and Information Security on systems, integrations, implementations, upgrades and changes affecting products or regulated processes.
Cybersecurity documentation and technical review
Apply and maintain established procedures, work instructions, templates, testing methodologies, risk assessments and supporting technical evidence.
Review deliverables from internal teams and third parties for technical integrity, consistency and regulatory alignment; recommend practical process improvements.
Cross-functional partnership and enablement
Act as the day-to-day cybersecurity subject matter expert for Regulatory Affairs, Quality, Engineering, Software, Product Development, IT, Clinical and Manufacturing.
Contribute to design reviews, risk reviews and issue resolution; escalate significant risks and constraints, and deliver knowledge transfer and technical training.
Hands-on security engineering, tooling and DevSecOps
Partner with developers, architects, systems engineers and DevOps to embed security in design, implementation, maintenance, code reviews and threat-modeling sessions.
Evaluate, select, configure and implement security tools; integrate scanning, automated checks and vulnerability detection into repositories and CI/CD pipelines.
Analyze SAST, DAST, SCA and penetration-testing results; prioritize findings, guide remediation, and verify that corrections are effective.
Support secure coding and engineering guidance, security test environments and controls such as authentication, authorization, encryption, API security, secure communications, software integrity and sensitive-data protection.
Troubleshoot security issues, implement agreed technical improvements and identify opportunities for automation, standardization and reuse across product platforms.
CANDIDATE PROFILE
Substantial hands-on experience in product or medical-device cybersecurity, spanning secure development, risk analysis, security testing and vulnerability management.
Ability to work closely with software and systems engineers, including practical exposure to security tooling, code or architecture reviews, and CI/CD security integration.
Capability to interpret security findings, define corrective actions, assess technical risk and document clear verification evidence.
Familiarity with regulated product development and the supporting documentation, quality and regulatory review processes.
Strong technical writing, stakeholder communication and cross-functional coordination skills; comfortable operating within an existing client governance framework
