Design Quality Engineer II

Design Quality Engineer II

Boston Scientific Peripheral Interventions is seeking a Design Quality Engineer II to help advance our product portfolio. In this role, you will collaborate across functions to ensure device safety, quality, and regulatory compliance, delivering exceptional products to our customers. As a key member of the Quality team, you will support the design and development of a next-generation mechanical thrombectomy device within the AngioJet product family. You will apply robust quality engineering methodologies that align with Boston Scientific, customer, and regulatory standards.

Your responsibilities will include:

• Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Supports departmental, functional, and divisional Design Quality goals and priorities.
• Executes methodologies to effectively meet individual and team objectives.
• Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
• Ensure adherence to the quality systems and Design Assurance SOPs and Boston Scientific's Product Life Cycle Process (PLCP).
• Apply critical thinking and engineering analysis to solve problems.

What we're looking for in you:

Required qualifications:

• Bachelor of Science in Mechanical / Biomedical Engineering or related discipline.
• 2+ years experience in design assurance or related field, or a combination of education and experience to perform at this level.
• Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems).
• Ability to travel up to 10%.

Preferred qualifications:

• Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management.
• Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills.
• Experience with Post Market Surveillance, EU MDR, and IEC 62366-1 (Usability).
• Ability to work independently and as part of a team.