Sr. S/W Quality Engineer

Location: Arden Hills US-MN, United States | US-MA-Marlborough, US-MN-Maple Grove

Department: Engineering

Work Location: onsite

Recruiter: Spencer Gregory Hale

Sr. S/W Quality Engineer

About this 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.

Your responsibilities will 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. 
• 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. 

What we’re looking for in you:

Minimal Qualifications:

• 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 Qualifications

• People leadership experience a preference

Requisition ID: 623805 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. 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., 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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.