Design Quality Assurance Engineer II - Urology

Boston Scientific • Georgetown, MA

4d

About The Position

Your responsibilities will include: Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6). Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues in a timely manner. Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals. Support internal and external regulatory audits as required.

Requirements

• Minimum of a Bachelor's Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
• Minimum of 2 years of related experience.
• Travel approximately <10%
• Experience in the Medical Device industry (quality and risk management) and medical electrical systems.
• Detailed understanding of ISO 13485, ISO 14971, and Quality System Regulations.
• Skillful problem solver, capable of facilitating the problem-solving process and driving to solutions in a timely manner.
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
• Strong communication skills (verbal & written)

Responsibilities

• Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6).
• Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues in a timely manner.
• Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals.
• Support internal and external regulatory audits as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees