Job Description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Software Quality Engineer on a Permanent basis to join our team.

Job Purpose:

Develops, modifies, applies, and maintains standards for Software Quality methods, processes and procedures which meet Boston Scientific and external regulatory requirements. Provides expertise and conducts evaluation of software systems validation activities including requirements, design, development, integration, test, verification, and implementation. Establishes methods for monitoring the compliance of software system processes, standards, and procedures. Coaches less experienced colleagues and executes on projects along with other members of the team. Role includes AI/IT/clinical/manufacturing/Quality software and computerized system validation and maintenance. Role requires expertise in software validation as it applies to both Waterfall and an Agile environment.

Key Responsibilities:

• Acts as an effective team member providing independent review and guidance on deliverables used to develop, implement and maintain AI/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 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 approve 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 actitivies and metrics to promote efficient and cost effective operations.

Education & Experience:

• Level 8 Hons Bachelor Degree (or higher) in Engineering or related fields
• 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)
• Some experience of AI applications.
• 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.

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com