{"id":3148638,"url":"https://alion.io/job/boston-scientific-senior-quality-design-engineer","title":"Senior Quality Design Engineer","company":{"id":1758528,"name":"Boston Scientific","domain":"bostonscientific.com","url":"https://alion.io/company/bostonscientific-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Eightfold","truth_index":{"grade":"B","score":79,"open_postings":78,"ghost_share":0.026,"stale_share":0.756,"repost_share":0.051,"time_to_fill_p50_days":30,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Galway, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":50000,"max_usd":86000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":63},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-08-31T18:45:59Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-29T04:05:02Z","board_verified":true,"closed_at":null,"days_open":58,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":58},"description":"Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\nAt 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.\nAdvancing possibilities for a brighter tomorrow\nWe are seeking a Senior Quality Design Engineer on a permanent basis to join our team.\nPurpose Statement:\nApply your engineering expertise to ensure patient safety and product excellence by joining the Design Assurance team within our IC/VT. 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.\nIn this highly visible role, you will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R&D, manufacturing, regulatory, and clinical. You will thrive in a high-performance culture that values diversity, innovation, global collaboration and a winning spirit - where continuous learning and meaningful impact are part of every project.\nKey Roles & Responsibilities:\nLead and apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.\nProvide senior-level quality engineering leadership on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.\nDrive 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.\nDevelop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.\nEstablish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.\nLead design change control activities, assessing product and process impacts while ensuring compliance and patient safety.\nMonitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.\nMentor junior engineers and contribute to the development of best practices that elevate team capability and performance.\nEducation and Experience:\nLevel 8 Bachelor of Science degree in Engineering or a related technical field.\nMinimum of 7 years' experience in quality engineering or design assurance within the medical device industry.\nDemonstrated expertise in risk management, design controls and product verification and validation.\nStrong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.\nProven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.\nStrong written and verbal communication skills.\nAbility to manage multiple priorities and navigate ambiguity in a fast-paced environment.\nPreferred qualifications:\nLevel 8 Honours degree in biomedical or mechanical engineering.\nExperience supporting structural heart, cardiovascular or implantable medical devices.\nCertification in quality engineering (e.g., CQE) or related credential.\nDemonstrated use of advanced quality tools and statistical methodologies.\nPassion for continuous improvement, talent development and building high-performing teams.\nAs 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.\nSo, choosing a career with Boston Scientific 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!\nTo search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers\nAt Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. 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 is committed to providing reasonable accommodations for applicants and employees with a disability. 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