Senior Quality Systems Engineer - Cybersecurity & Software Processes

bostonscientific•Maple Grove, MN

10h•$85,000 - $161,500•Hybrid

About The Position

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Boston Scientific ranked #2 among medical device companies on Forbes America's Best Places to Work for Engineers 2026 . Whether your passion lies in systems, software, human factors, or beyond, this is a place where you can grow your career and be part of something bigger—advancing science for life. The Senior Quality Systems Engineer – Cybersecurity & Software Processes is a senior-level technical leadership role responsible for defining, governing, and continuously improving cybersecurity-related processes within the Boston Scientific Quality Management System (QMS). This role ensures cybersecurity expectations are embedded, scalable, and sustainable across the full product lifecycle—from concept and design through post-market surveillance—while aligning with global regulatory, industry, and corporate standards. Acting as a corporate subject matter expert, this position partners across divisions and functions to integrate cybersecurity into software development, risk management, supplier controls, and digital health solutions. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

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.

Nice To Haves

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.

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.