Senior Design Assurance Engineer

Additional Location(s): N/A\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:\n\nBoston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.\n\nBoston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.\n\nApply your engineering expertise to ensure patient safety and product excellence by joining the Design Assurance team within our Structural Heart Valves division. As a Senior Design Assurance Engineer, you will support new product development and commercialized products that improve the delivery of care for patients around the world.\n\nIn this highly visible role, you will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R\u0026D, manufacturing, regulatory, and clinical. You will thrive in a high-performance culture that values diversity, innovation, global collaboration and a winning spirit \u2014 where continuous learning and meaningful impact are part of every project.\n\nWork model, sponsorship, relocation:\n\nThis role is on-site in Carlsbad, California, to support hands-on collaboration and cross-functional partnership. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is available for qualified candidates.\n\nYour responsibilities will include:\n\n\u25cf Lead and apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.\n\n\u25cf Provide senior-level quality engineering leadership on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.\n\n\u25cf Drive the implementation and continuous improvement of risk management activities, including hazard analysis, fault tree analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards.\n\n\u25cf Develop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.\n\n\u25cf Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.\n\n\u25cf Lead design change control activities, assessing product and process impacts while ensuring compliance and patient safety.\n\n\u25cf Monitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.\n\n\u25cf Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.\n\nQualifications:\n\nRequired qualifications:\n\n\u25cf Bachelor of Science degree in Engineering or a related technical field.\n\n\u25cf Minimum of 7 years\u0027 experience in quality engineering or design assurance within the medical device industry.\n\n\u25cf Demonstrated expertise in risk management, design controls and product verification and validation.\n\n\u25cf Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.\n\n\u25cf Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.\n\n\u25cf Strong written and verbal communication skills.\n\n\u25cf Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.\n\nPreferred qualifications:\n\n\u25cf Degree in biomedical or mechanical engineering.\n\n\u25cf Experience supporting cardiovascular implantable medical devices.\n\n\u25cf Certification in quality engineering (e.g., CQE) or related credential.\n\n\u25cf Demonstrated use of advanced quality tools and statistical methodologies.\n\n\u25cf Passion for continuous improvement, talent development and building high-performing teams.\n\nRequisition ID: 625287\n\nMinimum Salary: $ 89200\n\nMaximum Salary: $ 169500\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\nBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.\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