Senior Software Design Assurance Engineer

Senior Software Design Assurance Engineer Onsite Location(s): Arden Hills, MN, US 55112 Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance About the role: Were excited to offer a software-focused Senior Design Assurance Engineer to support a cross-functional team on development and maintenance of implantable and external devices and software within the Urology division. This position will support a significant product development project with high visibility, providing excellent growth potential and product development experience. The role will apply design controls throughout the software development lifecycle (SDLC), software verification and validation (V&V), risk management, regulatory and standards compliance, and ensure the protection of patient/user safety while meeting business needs. The Design Quality role supports the active implantable design process for both existing and new products. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. In this position, you can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA. Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position. Your responsibilities include: Participate in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V. Apply software application development procedures and provide support to demonstrate compliance through technical documentation generation. Have a thorough understanding of system and software design controls, participate in cross?functional team meetings, and software bug triage meetings to investigate and appropriately 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 (e.g., Hazard Analysis, FMEAs). Participate in cybersecurity discussions and assist with supporting activities, including security risk analysis. Lead and participate in software and electronic design reviews, design transfers, and all aspects of the Design Control process for the PCI Guidance products. Serve as an effective leader or team member in supporting quality disciplines, decisions, and practices. Assist in the design and development of software test cases and inspection procedures. Support regulatory submissions to notified bodies. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures. Required Qualifications Bachelors degree in engineering or a related discipline. A minimum of five years of experience in design assurance, quality, new product development, or related medical device/regulated industry experience. Understanding of Software Development Life Cycle (SDLC). Experience with software testing and issue investigation/resolution. Experience with issue tracking tools and requirements/test?management tools. Understanding of software configuration management (version control, Microsoft Office tools). Adaptable and effective 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. Medical device or other regulated industry experience. Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971), and software standards (IEC 62304 or IEC 82304). Experience in conducting and participating in code reviews. Requisition ID: 615961 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 (BSC) 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. 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) isnt just business, its personal. And if youre 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 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 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 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: Compliance, Testing, Medical Device Engineer, Medical Device, Risk Management, Legal, Technology, Engineering, Healthcare, Finance #J-18808-Ljbffr