Senior Design Quality Engineer

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.

We are seeking a Senior Design Quality Assurance (DQA) Engineer. You’ll be at the heart of that mission to support best-in-class commercialized products (laser consoles and fibers). Your contribution will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.

Key Responsibilities

• Partner with R&D, Regulatory Affairs, Clinical, and Manufacturing teams to ensure product quality and drive continuous improvement across the Laser Therapies portfolio.
• Serve as a Subject Matter Expert (SME), ensuring compliance with Boston Scientific's Quality Management System and applicable regulatory requirements.
• Provide independent quality reviews of design documentation, risk assessments, and verification and validation activities for new product development and changes to commercialized products.
• Investigate complex quality and technical challenges, analyze test results, and drive risk-based decisions and effective solutions.
• Provide Design Quality guidance to product development and sustaining engineering teams, ensuring compliance throughout the product lifecycle.
• Maintain and improve design control and risk management processes, ensuring alignment with applicable ISO, FDA, EU MDR, and internal quality requirements.
• Coordinate quality activities across multidisciplinary teams, supporting project milestones, continuous improvement, and technical knowledge sharing.
  
  

• Bachelor's degree (B.Sc.) in Engineering/ Science, or a related technical discipline.
• 4–6 years of relevant experience in Design Quality Assurance or a similar role.
• Experience in the medical device industry, working with multidisciplinary products -mandatory
• Certified Quality Engineer (CQE) certification- preffered
• Hands-on experience with medical device design controls, risk management, and product lifecycle management.
• Knowledge of ISO 13485, ISO 14971, FDA Quality Management System Regulation (QMSR), and EU MDR requirements.
• Experience supporting design changes, verification and validation activities, and sustaining engineering.
• Strong technical and analytical capabilities, with demonstrated problem-solving and decision-making skills.
• Excellent communication, interpersonal, and cross-functional collaboration skills.
• Self-motivated, proactive, and results-oriented, with the ability to manage multiple priorities.
• Strong teamwork skills and the ability to influence and collaborate effectively with cross-functional stakeholders.