Senior Software Quality Engineer - Global Device Software Steward Support

This Device Software Sub-Process Steward Support role teams with the Device Software Sub-Process Steward to help with leadership and oversight to the Device Software sub-process. The Device Software sub-process controls device software considered a finished medical device or used as a component, part, or accessory of a medical device developed, subcontracted, modified, or purchased. Quality System Stewards use the Best4 (Culture, Agility, Performance, Compliance) Strategy to enable our Quality Policy.Global Quality System Device Software sub-process maintain oversight of all processes in their assigned Sub-Process. Sub-Process Stewards work together to maintain their assigned Process(es) and ensure all responsibilities are fulfilled., Write applicable annual quality goals andobjectiveswith input from sites, divisions,regions,and leadership to align with Best4 and organizational strategies. Support and update goals andobjectivesthroughout the year.

* Best Agility:

* Monitor Device Software Sub-Process and implement process improvements based on performance feedback.

* Drive value improvement projects (VIP) to support organizational goals.

* Support acquisition integration as needed.

* Increase Quality System simplicity, efficiency and predictability with standardization and lean practices.

* Maintain andenhancesinternal and external relationships in support of the Global Quality SystemProcess/Sub-Process.

* Best Performance

* Monitor and mitigate Quality System Process compliance risk whereappropriate.

* Lead or oversee quality projects of majormagnitudeand scope.Provide input to overall qualityproject portfolio and project priorities.

* Determineif changes are reportable to notified bodies.

* Initiative corporate preventive CAPAs and own orparticipatein corporate preventive CAPA teams.

* Create, implement, and sustain measures and metrics tomonitorDevice SoftwareSub-Process health.

* Provide metrics,dataand analysis for management review.

* Best Compliance:

* Establish andmaintainGlobalQuality System Device Software Sub-Processto ensure compliance with applicable quality and regulatory requirements.

* Review of new Laws RegulationsStandards andGuidance’s (LRGS)andthe implementation of new requirements into the BSC Quality System.

* Communicate new and updated requirements.

* Provide subject matterexpertiseand support for corporate and site internal and external audits.-

* Review quarterly dataperQuality System ProcessCompliance Assessment.

* Support theauditnon-conformance response strategies.

* IdentifyGlobalQuality System DeviceSoftwareSub-Processtraining requirements.

* Support corporate NCEP & CAPA Processes.

* Assess reportability of substantial Quality System Changes.

* Ensuring quality records are created,maintainedand dispositioned.

Bachelor’s level degree in Science/Engineering/Computer Science/Software Engineering disciplineand/orMinimum of4years of related experiencein the Medical Device regulated industry.

* Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485,IEC 62304; ISO14971; FDAGuidance - General Principles of Software ValidationandComputer Software Assurance for Production and Quality System Software.

* Must havegoodunderstanding of quality system requirements and how each quality system element connects.

* Comfortable speaking and presenting to leadership

* Strong written and verbal communication skillsin English

* Experience managing projects and project deliverables to completion

* Comfortable working independently and as part of a cross-functional team

* Ability to manage multiple priorities

* Proficient in Microsoft Office

* Works willingly and effectively with others in and across the organization toaccomplishteam goalswith excellent interpersonal and networking skills.

* Values people’s opinions and encourages knowledge sharing.High levelof energy,driveand enthusiasm

* Knowledge ofSoftware Engineering Principles andSoftware Development Life Cycle (SDLC)

* Ability to work independently and collaborate with cross-functional teams to complete projects

* Strong critical thinking and analytical skills: process and results-oriented

* Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively

Preferred Qualifications: * Device Software Engineering Experience, including:

* Device SoftwareDevelopment

* Device Software Testing / Verification

* Risk Management

* Cybersecurity

* Artificial Intelligence / Machine Learning

* Agile Practices

* Experiencein supporting and enhancing theQMSprocessesincluding:

* Device Software Development

* Design Controls

* Risk Management

* Post Market and PremarketCybersecurity

* Experience working with Medical DeviceSoftwareAdvocacy, Standards and Professional Organizations(i.e.AAMI; MDIC; IEC; FDA;AdvaMed; NIST; IMDRF)

* Formal Project ManagementExperience

* CAPA, Vendor Controls, ComplaintHandlingandInternal/External AuditsExperience

* Software Development Tools Experience(i.e.Jira; Cockpit;Github;Codenvy;Bitbucket)

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.