Boston Scientific · 16 hours ago
Sr. S/W Quality Engineer
Arden Hills, MN
Full-time
Onsite
Mid, Senior Level
$85K/yr - $162K/yr
6+ years expBoston Scientific is a leading medical device company that develops innovative solutions for healthcare. They are seeking a Senior Software Quality Engineer to ensure compliance with software quality standards and regulatory requirements, provide expertise in software validation, and support continuous improvement initiatives.
Medical DeviceHealthcareHealth CareMedical
Responsibilities
Acts as an effective team member providing independent review and guidance on deliverables used to develop, implement and maintain IT/clinical/manufacturing/quality software
Acts as a subject matter expert on software validation to guide/ coach/ train project teams on effective and efficient implementation of BSC software validation processes
Demonstrate mastery of the software validation processes at BSC
Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards and regulatory requirements
Works with the management to understand priorities and plans/provides input to resource and time allocation accordingly
Plays key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables. Demonstrate the ability to lead, acknowledge, develop, communicate & implement a validation strategy to ensure compliance
Guides implementation of enterprise systems solutions through planning, system integration, and verification and validation activities
Proactive involvement in continuous improvement activities while ensuring that Boston Scientifics’ software systems are defensible for regulatory requirements
Contributes to the development, review and / or approval of SOPs and supporting Work Instructions
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Software verification and validation activities
Communicates the value of the Software Quality process at Boston Scientific and champions departmental or cross-functional software validation initiatives. Ensures buy-in from project team members to the disciplines, decisions and practices of the Software Validation
Provides structured Quality Assurance activities and metrics to promote efficient and cost-effective operations
Qualification
Required
Bachelor's level degree in Science/Engineering/Software discipline
6 years of related experience, including 3+ years' experience in Software Quality and validation
Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
Must have good understanding of quality system requirements and how each quality system element connects
Some experience in working with ‘Agile' software development and validation methodologies
Some experience/knowledge of work management and testing tools (such as JIRA, Xray, qTest)
Experience working with a diverse population of internal and external customers
Comfortable speaking and presenting to leadership
Strong written and verbal communication skills
Creative and innovative thinking skills
Experience managing projects and project deliverables to completion
Comfortable working independently and as part of a cross-functional team
Ability to manage multiple priorities and work without ambiguity
Preferred
People leadership experience a preference
Benefits
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any 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 long-term incentives (subject to plan eligibility and other requirements).
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
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
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
Medical Device Network
2026-02-10
2026-02-09
Company data provided by crunchbase