Leading software verification and cybersecurity efforts for medical device portfolio
Overseeing planning and execution of verification and validation activities
Ensuring regulatory compliance via adherence to company’s Quality systems policies
Implementing secure coding practices
Reviewing and preparing clear, audit-ready documentation for regulatory submissions
Manage and mentor technical teams, drive continuous improvement initiatives
Supporting the supplier audit process, CAPA process, and other quality related process regarding cybersecurity risk management

Requirements

Bachelor’s degree in Computer Science, Cybersecurity or related degree, or equivalent
7 years of experience in software development or verification in a private, public, government, or military environment
3 years leadership experience in a private, public, government, or military environment
Experience in medical device software or other regulated industry with equivalent software safety and security standards
Proven experience in cybersecurity practices for software systems
Experience in crafting design Verification strategies, processes, resources and testing activities
Strong test management skills
Excellent verbal and written communication skills
Demonstrated ability to present technical information effectively
Experience condensing complex requirements into specific and measurable test objectives
Ability to work in a fast-paced environment
Certifications in cybersecurity (e.g., CISSP) or quality management (e.g., Six Sigma)
5 years relevant design control, risk management, design transfer and Quality Management System experience within an FDA regulated industry
Familiarity with tools such as Azure DevOps, JIRA, or similar platforms
Experience with risk management and statistical process control

Benefits

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

software verificationcybersecuritysecure coding practicesdesign verification strategiestest managementrisk managementstatistical process controlquality management systemsregulatory compliancesoftware development

Soft Skills

leadershipcommunicationmentoringcontinuous improvementpresentation skillsability to work in fast-paced environmentorganizational skillsinterpersonal skillsproblem-solvingattention to detail

Certifications

CISSPSix Sigma