Boston Scientific Design Quality Engineer II 

United States, Massachusetts, Marlborough 

888509018

Spencer Gregory Hale

Your responsibilities will include:

• Act as an effective leader or cross-functional team member in supporting quality disciplines, decisions, and practices.
• Effectively works with and influences cross-functional teams during the Design Change process to ensure proposed changes to products are systemically / thoroughly analyzed, assessed, controlled and implemented appropriately (i.e., EN 13485 / CFR820).
• Support planning, updating and maintenance of product Risk Management documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (i.e., EN 14971).
• Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6).
• Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements.
• 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.

Required Qualifications:

• 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%

Preferred Qualifications:

• 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)

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.