Principal Design Quality Engineer

Additional Location(s): US-TX-Austin\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s 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\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions. \n\nAbout the role: \nThe Principal Design Quality Engineer is a seasoned professional responsible for championing quality excellence, regulatory compliance, and continuous improvement across the product development lifecycle. This role supports a design site within the Endoscopy Division, with focus areas including New Product Development (NPD), Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.\n\nAs a quality leader within cross-functional teams, this role plays a critical part in shaping the direction of product programs and influencing company-wide initiatives through technical depth, strategic insight, and collaborative leadership.\n\n* * *\n\nWork model, sponsorship: \nAt Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Austin, TX office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.\n\n* * *\n\nYour responsibilities will include: \n\u25cf Act as the primary quality representative on cross-functional teams, influencing project direction and ensuring alignment with regulatory requirements and best practices.\n\n\u25cf Lead execution of quality deliverables such as Project Design \u0026 Development Plans, Field Assessment Plans, Design Changes, and Design \u0026 Usability Validation Plans.\n\n\u25cf Drive the creation and execution of Risk Management deliverables in compliance with ISO 14971, with a focus on patient safety.\n\n\u25cf Guide the successful completion of major programs and projects, functioning in a project leadership role when required.\n\n\u25cf Interface with senior management on strategic initiatives requiring coordination across organizational units.\n\n\u25cf Represent the division in cross-divisional projects and define quality system requirements.\n\n\u25cf Lead complex problem-solving activities using structured methodologies (e.g., 5 Whys, Is-Is Not, DMAIC, Six Sigma).\n\n\u25cf Provide technical leadership and mentorship to engineering teams, fostering a culture of learning and excellence.\n\n\u25cf Coach team members on quality engineering principles and structured problem-solving techniques.\n\n\u25cf Communicate quality priorities across departments, drive alignment on initiatives, and integrate quality into key business decisions.\n\n\u25cf Identify and implement best-in-class practices for quality engineering systems and proactively recommend improvements.\n\n\u25cf Serve as subject matter expert during internal and external audits; support regulatory submissions and technical writing as needed.\n\nRequired qualifications: \n\u25cf Bachelor\u2019s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field\n\n\u25cf Minimum of 7 years\u0027 experience in engineering within the medical device industry\n\n\u25cf In-depth knowledge of U.S. and international medical device regulations, including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971\n\n\u25cf Strong technical expertise in quality engineering, design controls, and risk management\n\n\u25cf Experience leading structured problem-solving using tools such as DMAIC, 5 Whys, or Six Sigma\n\n\u25cf Travel approximately 10\u201320%\n\nPreferred qualifications: \n\u25cf 10+ years\u0027 experience in medical device engineering\n\n\u25cf Expertise in Usability and Human Factors Engineering\n\n\u25cf Proficiency with Minitab or similar statistical analysis tools\n\n\u25cf Six Sigma Black Belt certification\n\n\u25cf Proven ability to mentor, influence, and guide engineering teams and cross-functional stakeholders\n\n\u25cf Excellent communication and presentation skills with the ability to collaborate across functions and levels\n\n\u25cf Strategic mindset with the ability to execute hands-on and drive both short-term impact and long-term improvement\n\n#LI-Hybrid\n\nRequisition ID: 621612\n\nMinimum Salary: $ 97000\n\nMaximum Salary: $ 184300\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will 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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.\n\nCompensation 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).\n\nCompensation 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).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nAs a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most \u2013 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 \u2013 as a global business and as a global corporate citizen.\n\nSo, choosing a career with Boston Scientific (NYSE: BSX) isn\u2019t just business, it\u2019s personal. And if you\u2019re 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!\n\nAt 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. \n\nBoston 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.\n\nPlease 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\u2019s policies or protocols change with regard to COVID-19 vaccination.\n\nAmong 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. \n