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. Principal Quality Assurance Engineer About the Role: At Boston Scientific, the Principal Quality Assurance Engineer is a professional with wide-ranging experience and expertise in Sustaining quality engineering. This person will develop, establish, and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. Provides focused quality engineering support within new product development, operational, or system/services support. This is an onsite position based in Arden Hills, MN. Your Responsibilities Include: * Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives. * Influence and collaborates with the Product Development & Engineering team to ensure proper execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Validation Plans. * Provide quality and manufacturing input and coaching for product and process development and product sustaining activities, such as reduction and control of Manufacturing process defects (scrap, nonconforming material, customer complaints)byleading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. * May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria. * Develops and implements product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs. * Provides project direction, coaching, and mentoring for quality engineering and technical team personnel supporting the product line(s). * Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results. * Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. * Supports internal and external regulatory audits. * Provides technical leadership to business unit. Advises management on potential improvements or enhancement to quality systems and processes. What We're Looking For: Required Qualifications: * BS in Biomedical, Mechanical Engineering or related degree. * Minimum of 8 years of medical device engineering experience. * In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements and New Product development * Strong communication and presentation skills. * Solid technical writing skills. * Travel <10%, if required Preferred Qualifications: * 10+ years of medical device engineering experience preferred. * Experience supporting Finish Devices and Electrophysiology Division products. * Experience in Product Line Acquisition & Transfers. Requisition ID:587620 As a leader in edical 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 freeworkplace. 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