Boston Scientific · 3 hours ago
Senior Quality Systems Engineer - Cybersecurity & Software Processes
Marlborough, MA
Full-time
Hybrid
Senior Level
5+ years expBoston Scientific is a leader in medical science committed to solving significant health challenges. The Senior Quality Systems Engineer – Cybersecurity & Software Processes will define and improve cybersecurity-related processes within the Quality Management System, ensuring compliance across the product lifecycle while integrating cybersecurity into various functions.
Health CareMedicalMedical Device
No H1B
Responsibilities
Serve as a global Quality Systems partner supporting multiple divisions, regions, and product portfolios, ensuring consistent interpretation and application of cybersecurity QMS requirements
Lead and actively participate in Cybersecurity and Software Quality Communities of Practice, facilitating cross-divisional forums to share best practices, lessons learned, and emerging risks
Drive alignment, standardization, and maturity improvements of cybersecurity processes across global teams, acting as a key escalation and decision-support resource
Lead complex, cross-functional, and enterprise-level projects integrating cybersecurity expectations into the Quality Management System
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
Identify risks, issues, and constraints, develop mitigation strategies, and drive timely resolution to ensure sustainable and auditable outcomes
Lead the development, revision, implementation, and sustainment of cybersecurity-related QMS documentation
Embed cybersecurity requirements across the software development lifecycle, design controls, software risk management, and supplier controls
Provide expert guidance, coaching, and training to global partners to strengthen organizational cybersecurity capability
Oversee cybersecurity risk management activities, including threat modeling and risk acceptance processes
Support global processes for patching, SBOM management, CVE monitoring, and coordinated vulnerability disclosure
Define and support supplier cybersecurity assessment, qualification, and ongoing monitoring processes
Lead cybersecurity QMS integration activities for acquisitions and newly onboarded organizations
Monitor evolving regulatory, standards, and threat landscapes and translate changes into QMS updates and organizational readiness activities
Promote behaviors aligned with Boston Scientific’s Quality Policy, Values, and commitment to patient safety, product quality, and data protection
Qualification
Required
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
Preferred
Experience with medical device cybersecurity frameworks, threat modeling, SBOM management, and CVE analysis
Experience leading corporate or global Quality Management System initiatives
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
Benefits
Variable compensation governed by the Sales Incentive Compensation Plan
Core and optional benefits offered at BSC
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
WSJ.com: US Business
2026-02-05
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