Software Quality Engineer II - Complaint Investigation Site (CIS)
Boston Scientific Corporation
Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 This Role:This role leads investigational efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on conducting investigations of returned products related to complaints, focusing primarily on Lithotrispy laser systems. Reviews return device data, completes investigation documentation and coding, and ensures conclusions align with testing results. Collaborates cross-functionally with teams such as Design Quality, R&D, Supplier Management, and Operations to support thorough analysis and risk understanding. Escalates product issues, drives continuous improvement, and reports findings. Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least four (4) days per week. Relocation assistance:Relocation assistance is not available for this position at this time.Visa sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your Responsibilities Will Include:Analyze system logs and post-market surveillance data to determine event root causes and identify safety or quality issues.Lead product signal investigations, document findings, and drive corrective actions, including NCEPs and CAPAs as needed.Partner cross-functionally to implement compliant process improvements that enhance CIS operations.Communicate product performance insights to leadership, design teams, and customers through reports, presentations, and inquiries.Ensure compliance with quality, regulatory, and patient safety requirements.Required Qualifications:Bachelor’s degree in engineering or other related technical/scientific discipline Preferred Qualifications2+ years of post-market complaint support or other related experienceExperience with capital equipment and/or log file analysisKnowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards Experience in Medical Device industry or a Quality organization Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook Ability to collaborate and influence across multiple, cross-functional teams Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis Self-starter with the ability to identify improvement opportunities Requisition ID: 635969Minimum Salary: $ 71500Maximum Salary: $ 135800The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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 transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn.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.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.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.
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