Senior Quality Systems Engineer - Cybersecurity & Software Processes

Boston Scientific • Arden Hills, MN

12h

About The Position

Your responsibilities will include: Develop and manage project plans, timelines, milestones, dependencies, and deliverables using appropriate project management methodologies (waterfall, hybrid, or agile). Coordinate resources across Global Quality, R&D, Regulatory, IT, Cybersecurity, and Supply Chain functions. Provide expert guidance, coaching, and training to global partners to strengthen organizational cybersecurity capability. Support global processes for patching, SBOM management, CVE monitoring, and coordinated vulnerability disclosure.

Requirements

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Quality, or a related technical field.
• Minimum of 5 years' experience in a regulated medical device or highly regulated software environment.
• Strong working knowledge of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and FDA medical device cybersecurity guidance.
• Demonstrated experience leading cross-functional or enterprise-level initiatives.
• Strong written and verbal communication skills with the ability to influence across functions and levels.
• Experience with medical device cybersecurity frameworks, threat modeling, SBOM management, and CVE analysis.
• Experience leading corporate or global Quality Management System initiatives.

Nice To Haves

• Familiarity with AI/ML-related regulatory guidance and digital health cybersecurity considerations.
• Project Management certification (PMP, Agile, or equivalent).
• Advanced degree in a relevant discipline.

Responsibilities

• Develop and manage project plans, timelines, milestones, dependencies, and deliverables using appropriate project management methodologies (waterfall, hybrid, or agile).
• Coordinate resources across Global Quality, R&D, Regulatory, IT, Cybersecurity, and Supply Chain functions.
• Provide expert guidance, coaching, and training to global partners to strengthen organizational cybersecurity capability.
• Support global processes for patching, SBOM management, CVE monitoring, and coordinated vulnerability disclosure.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level