Senior Software Quality Engineer

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

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.

About the role:
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 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.
This position is hybrid with the expectation to be in the office 2 to 3 days per week.  The position can be located in Marlborough, MA, Arden Hills, MN or Maple Grove, MN.
Key responsibilities include:

• 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 (examples include GSM, Spreadsheet Validation). 
• 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 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. 

Minimal qualifications:

• Bachelor’s level degree in Science/Engineering/Software or related discipline 
• 6 years of related experience, including 3+ years’ experience in Software Quality Assurance and validation
• Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
• Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards and regulatory requirements.
• Must have good understanding of quality system requirements and how each quality system element connects
• Experience in working with ‘Agile’ software development and validation methodologies
• Some experience/knowledge of work management and testing tools (such as JIRA, Xray, qTest)
• Strong written and verbal communication skills 
• Experience managing projects and project deliverables to completion 
• At times, this position requires up to 25% travel (domestic and international)

Preferred qualifications:

• Creative and innovative thinking skills 
• Ability to manage multiple priorities and work without ambiguity
• Comfortable working independently and as part of a cross-functional team 
• Experience working with a diverse population of internal and external customers 
• People leadership experience
• Comfortable speaking and presenting to leadership 

#LI-Hybrid

Requisition ID: 560583

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.