Senior Software Design Assurance Engineer

Senior Software Design Assurance Engineer Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance Boston Scientific offers an exciting opportunity for a Senior Design Assurance Engineer to support a cross?functional team in the development and maintenance of capital equipment and software within the Interventional Cardiology division. This role supports a high?visibility product development project, provides growth potential, and involves applying design controls, SDLC, V&V, risk management, product development, and regulatory compliance. The engineer collaborates closely with cross?functional teammates to protect patient safety and meet business needs. Relocation assistance is available for this position. Boston Scientific will offer sponsorship or take over sponsorship of an employment visa for this position. Hybrid work model: employees must be in the local office at least three days per week. Your responsibilities include: Implement new product software, including risk management (ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V. Apply software application development procedures and support compliance through technical documentation generation. Understand system and software design controls; participate in cross?functional team meetings and software bug triage meetings to investigate and disposition internal software bugs and field issues. Apply systematic problem?solving methodologies to identify, prioritize, communicate, and resolve quality issues (e.g., software bugs). Work within a cross?functional team to identify and implement effective controls and support product development from concept through commercialization. Update and maintain software risk management tools (hazard analysis, FMEAs). Lead and participate in software and electronic design reviews, design transfers, and all aspects of Design Control for PCI Guidance products. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Participate in cybersecurity?related discussions and assist supporting activities. Assist in the design and development of software test cases and inspection procedures. Support regulatory submissions to notified bodies. Maintain compliance with the Quality Policy and all documented quality processes and procedures. What were looking for: Required Qualifications Bachelors degree in engineering or a related field. Minimum of 5 years experience in design assurance, quality, new product development, or related medical device/regulatory industry experience. Understanding of Software Development Life Cycle (SDLC). Experience with software testing and issue investigation/resolution. Experience with issue?tracking tools (JIRA) and requirements/test?management tools. Understanding of software configuration management (version control, Microsoft Office tools). Adaptable collaborator in a team environment and in self?directed work. Ability to work in a highly matrixed and geographically diverse business environment. Demonstrated use of quality tools/methodologies. Preferred Qualifications Prior Software Design Assurance experience. Experience in medical device or other regulated industry. Strong knowledge of QSR, Risk Management standards (ISO 14971), and software standards (IEC 62304 or IEC 82304). Experience conducting and participating in code reviews. Requisition ID: 611665 Minimum Salary: $82,600 Maximum Salary: $156,900 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific see www.bscbenefitsconnect.com will vary based on the 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. Please be advised that certain U.S. 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 Companys 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. Nearest Major Market: Minneapolis Job Segment: Testing, Compliance, Medical Device Engineer, Medical Device, Design Engineer, Technology, Legal, Engineering, Healthcare #J-18808-Ljbffr