Senior Medical Device Cybersecurity Quality Engineer

Boston Scientific

Marlboro (MA)

On-site

USD 89,000 - 170,000

Full time

4 days ago

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Job summary

The Senior Cybersecurity Quality Systems Engineer at Boston Scientific operates within the Global Software Quality organization to ensure cybersecurity quality across medical devices and software. This role provides operational support by independently reviewing cybersecurity documentation and objective evidence to verify alignment with Quality System processes and regulatory requirements.

The role also monitors evolving cybersecurity regulations and translates them into Quality System

Qualifications

Bachelor's degree in a technical field (CS/Engineering or related).
5+ years in medical device software, cybersecurity, or software quality.
Experience in regulated medical device QMS and quality processes.
Knowledge of FDA guidance, IEC 62304, ISO 14971, and software development controls.

Responsibilities

Serve as the Global Software Quality SME for cybersecurity Quality System processes.
Review cybersecurity documentation and evidence for regulatory alignment.
Assess completeness and traceability of cybersecurity outputs and SBOMs.
Provide actionable recommendations to product teams on quality and compliance.
Collaborate with R&D, Product Security, Regulatory Affairs, and Quality teams.