Design Quality Engineer II

About the role

Boston Scientific seeks a Design Quality Engineer II to support the Endoscopy division. You will work within a cross‑functional team to ensure product safety, compliance, and performance for existing medical devices.

Key responsibilities

• Provide design quality assurance activities in an FDA/EU MDR regulated environment, collaborating with R&D, Regulatory, Manufacturing and other functions.
• Support design changes, corrective actions, and cost‑reduction initiatives, including creation and maintenance of risk management documentation such as DFMEA, FTA and usability engineering files.
• Apply systematic problem‑solving methods (5 Whys, DMAIC, cause‑and‑effect analysis) to identify and resolve quality issues.
• Participate in internal and external audits and value‑improvement projects.

Required profile

• BS in Biomedical, Mechanical Engineering or related field.
• Minimum 2 years of medical‑device engineering experience.
• Fluent in English and Spanish with strong communication skills.
• Willingness to travel as needed.

Required skills

• Microsoft Office Suite.
• Minitab or equivalent statistical analysis software.
• Knowledge of Design Controls, Risk Management, DFMEA, Fault Tree Analysis, and usability engineering.
• Familiarity with FDA QSR, ISO 13485, ISO 14971, IEC 60601 standards.