Systems Design Assurance Principal Engineer

Systems Design Assurance Principal Engineer Onsite Location(s): Maple Grove, MN, US, 55311 About the role: Boston Scientific is currently recruiting for a Systems Design Assurance Principal Engineer in our Maple Grove, MN location. This is an exciting opportunity to participate in the development of single-use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of Boston Scientific. Your responsibilities will include: Lead or mentor the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR. Effectively communicate within the project team, across functions, and elevate issues above the project team as appropriate. Develop solutions to complex and diverse technical problems that require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Influence cross-functional plans, guide overall project strategy, know when to solicit feedback, and facilitate project decisions. Build quality into all aspects of work by maintaining compliance with all quality requirements, defending the work of their team, as well as supporting internal and external regulatory audits. Participate as a division representative in cross-divisional projects defining the quality system and may advise management on potential improvements to the quality systems and processes. Support functional and divisional design quality goals and priorities. What we're looking for in you: Required qualifications: Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline. 7+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience. Understanding of electrical safety standards IEC 60601. Experience with reliability testing. Demonstrated use of Quality tools/methodologies. Preferred qualifications: Experience with class III medical devices. BS in Electrical Engineering. Previous R&D experience. Strong knowledge of QSR and ISO standards. ASQ certification. Requisition ID:601024 Minimum Salary: $99,100 Maximum Salary: $188,300 The anticipated compensation listed above 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. 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. 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 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. #J-18808-Ljbffr

Created: 2025-03-05