Boston Scientific · 9 hours ago
Sr. Global Software Quality Engineer
Arden Hills, MN
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
6+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. The Sr. Global Software Quality Engineer will develop and maintain standards for software quality methods, ensuring compliance with regulatory requirements while collaborating with cross-functional teams on software validation and quality assurance processes.
Health CareMedicalMedical Device
No H1B
Responsibilities
Act as an effective team member providing independent review and guidance on deliverables related to the development, implementation, and maintenance of device IT, clinical, manufacturing, quality, and quality system software
Demonstrate mastery of software validation processes and quality standards
Apply fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements
Collaborate with management to understand priorities and provide input on resource and time allocation
Provide full guidance on the acceptability of software quality and validation deliverables and lead the development and execution of validation strategies
Guide implementation of enterprise system solutions and device commercialization efforts through system planning, integration, and validation activities
Drive continuous improvement while ensuring defensibility of Boston Scientific software systems and device software to regulatory bodies
Contribute to the development, review, and/or approval of SOPs and supporting work instructions
Effectively communicate software verification and validation concepts across all levels of the organization
Champion the software quality process and lead or support departmental and cross-functional validation initiatives
Deliver structured quality assurance activities and metrics to support efficient, cost-effective operations
Qualification
Required
Bachelor's degree in science, engineering, or software discipline
Minimum of 6 years' experience in a related role, including at least 3 years' experience in software quality assurance and validation
Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304, and cGxP for medical devices
Strong understanding of quality system requirements and their interdependencies
Experience with Agile software development and validation methodologies
Experience supporting enterprise system validations (e.g., SAP) and/or digital health/SaMD products
Some knowledge of cybersecurity and security risk analysis
Familiarity with work management and testing tools (e.g., JIRA, qTest)
Comfortable communicating and presenting to leadership
Strong verbal and written communication skills
Creative and innovative problem-solving skills
Proven ability to manage projects and deliverables through to completion
Experience working independently and collaboratively in cross-functional teams
Strong organizational skills with the ability to manage multiple priorities
Preferred
Experience or knowledge of design controls, risk management, and labeling processes
Experience or knowledge of GenAI applications
Understanding of risk management per ISO 14971 and AI risk assessments per the EU AI Act
Experience with AI implementation and monitoring plans
Familiarity with CAPA, vendor controls, complaint handling, and external audits
Basic understanding of HIPAA, GDPR, and data security regulations
Experience or knowledge of digital platforms and development tools such as Salesforce, GitLab, Bitbucket, and JIRA
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
$10.02B2025-02-21Post Ipo Debt· $1.58B
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
2026-01-24
2026-01-23
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