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Requirements
8 or more years of experience in medical-device product cybersecurity, including regulatory submission support.
Proficiency in FDA premarket/postmarket cybersecurity requirements and ISO 14971 risk-management integration.
Experience with IEC 62304 regulated software development lifecycle and design-control documentation.
Experience conducting STRIDE-based threat modeling, attack-surface analysis, and security architecture reviews.
Experience with vulnerability management, including CVSS 3.1 scoring, MITRE mapping, and SBOM/supply-chain security.
Strong technical depth in embedded systems, secure communications, encryption, key management, and secure boot/firmware protection.
Responsibilities
Develop product security plans, threat models, and cybersecurity risk assessments for connected medical devices.
Integrate cybersecurity risks into ISO 14971 patient-safety and product risk-management analyses.
Conduct threat modeling, attack-surface analysis, and security architecture reviews for embedded and software-based devices.
Oversee vulnerability assessments and penetration testing, scoring findings and developing remediation plans.
Manage SBOMs, evaluate third-party components, and incorporate security into CI/CD and DevSecOps workflows.
Author FDA-ready documentation, including MDS2 forms and security white papers, to support regulatory submissions.
Founded in 1999, Resourcesoft, Inc. is a leading Technology Consulting and Professional Services organization. Headquartered in Marlborough, MA, the company serves the technology needs of its clients nationwide. Resourcesoft has often been recognized by prominent rating agencies for its exemplary growth and stability. With over two decades of industry experience, the Company has evolved as a front runner in enabling project optimization. We partner with leading organizations to provide technology solutions within the financial, insurance, education, government, publishing, healthcare and pharmaceutical domains. We take pride in mentoring a workforce that is well positioned to respond to the emerging IT trends and needs. With the employees at the crux of every business endeavor, our success is driven by our expertise in pairing the right talent with the best jobs in the technology sector. We forge long term, personalized relationships with our employees to advance their career to the next level. We engage them in technology centric client projects that provide opportunities for them to evolve, innovate and deliver world class products and services. Our career opportunities offer challenging assignments and exposure to emerging and cutting edge technologies. We are committed to providing our employees with the tools necessary to accelerate their career progression, while maintaining a healthy, work-life balance. We are deeply committed to providing a workplace ambience that is both challenging and fulfilling.
Resourcesoft is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
For more information about Resourcesoft and our services, please visit our website.
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