Senior Quality Design Engineer

Boston Scientific; Galway; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Boston Scientific is seeking a Senior Quality Design Engineer to join the Design Assurance team in Ireland. You will lead cross-functional NPD initiatives, shape design strategy, and drive risk management to ensure patient safety and product excellence.

You will develop verification and validation protocols, maintain Design History Files, and lead change control while collaborating with R&D, regulatory, and manufacturing teams to deliver high-quality medical devices worldwide.

Formación

• BSc in Engineering or related technical field.
• 7+ years in quality engineering or design assurance in medical devices.
• Knowledge of ISO 13485 and ISO 14971.
• Proven cross-functional leadership and influence.

Responsabilidades

• Lead senior-level quality engineering on cross-functional NPD teams.
• Ensure robust design inputs, verification and validation plans.
• Drive risk management activities per ISO 14971.
• Develop and approve DHF documentation and design outputs.
• Lead design change control and assess product/process impacts.
• Monitor field performance and drive CAPAs as needed.
• Mentor junior engineers and share best practices.

Conocimientos

Problem solving

Quality leadership

Cross-functional collaboration

Statistical methods

Risk management

Regulatory compliance

Communication skills

Educación

BSc in Engineering

Descripción del empleo

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.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Quality Design Engineer on a permanent basis to join our team.

Purpose Statement:

Apply 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.

In 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.

• Lead and apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.
• Provide senior-level quality engineering leadership on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.
• 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.
• Develop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
• Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
• Lead design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
• Monitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.
• Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.

Education and Experience:

• Level 8 Bachelor of Science degree in Engineering or a related technical field.
• Minimum of 7 years' experience in quality engineering or design assurance within the medical device industry.
• Demonstrated expertise in risk management, design controls and product verification and validation.
• Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.
• Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.

Preferred qualifications:

• Level 8 Honours degree in biomedical or mechanical engineering.
• Experience supporting structural heart, cardiovascular or implantable medical devices.
• Certification in quality engineering (e.g., CQE) or related credential.
• Demonstrated use of advanced quality tools and statistical methodologies.
• Passion for continuous improvement, talent development and building high-performing teams.

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.

At 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. Should you require a reasonable accommodation during the recruitment process, please email [e-mail] .