Senior Quality Systems Engineer - Cybersecurity & Software Processes

Senior Quality Systems Engineer – Cybersecurity & Software Processes

Onsite Location(s):

Maple Grove, MN, US, 55311

Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove

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.

• 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.

• 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.
• 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.

Requisition

Minimum Salary: $85,000

Maximum Salary: $161,500

At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non‑exempt (hourly), non‑sales roles may also include variable compensation from time to time (e.g., overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non‑sales roles may also include variable compensation, i.e., annual bonus target and…