Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At 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 the role: The Senior Design Assurance Engineer will lead cross functional teams to determine actionable root cause and implement effective solutions for issues impacting commercial Cardiac Rhythm Management (CRM) product performance.This role is a great fit for an individual who has, or is seeking, leadership and problem-solving experience, with an innate technical curiosity.This role also provides great exposure to the intricacies of how CRM products function, are designed, and the many parts of the organization that support their commercial use. This Senior Design Assurance Engineer will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, and Quality to achieve optimal results. This Senior Design Assurance Engineer will serve as liaison between the company and the various governmental agencies worldwide. Your Responsibilities Will Include: Leads cross-functional teams on product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Product Inquiry Reports (PIRs), and Corrective and Preventive Actions (CAPAs). Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not. Creates, maintains, and enhances cross-functional team relationships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues. Creates and maintains detailed investigation documentation following Good Documentation Practice guidelines. Creates, reviews, and approves Quality System records for NCEPs, PIRs, and CAPAs.May represent NCEPs, PIRs, and CAPAs in internal and external audits. Presents updates in formal and informal reviews with all levels of the organization. Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Monitors and ensures compliance with company policies and procedures. Required Qualifications: Minimum of a Bachelor's degree in engineering or related discipline Minimum of 5 years of related experience Medical Device or regulated industry experience Experience with NCEP and/or CAPA Proficient use of Microsoft Teams, Word, PowerPoint, and Excel Preferred Qualifications: Experience in CRM (Operations Quality, Design Assurance, Post-market Quality, or R&D) Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD) Experience with medical device software lifecycle and risk management Experience leading projects across functions and across sites Able to effectively support multiple high priority deliverables in parallel Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise Project Management and/or Technical Leadership experience Requisition ID:575900 Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in c mpliance with the applicable law. 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) isn't just business, it's personal. And if you're 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 is proud to be an equal opportunity and affirmative action employer. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. 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. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran