Boston Scientific is a worldwide and diverse company who puts patients first. As a Design Quality Assurance Engineer II, you’ll work with high-performing cross-functional teams to sustain commercialized Visualization products, ensuring their safety, quality, and compliance while continuously improving their value.
Act as an effective 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
Qualification
Required
Minimum of a Bachelor's Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
Minimum of 2 years of related experience
Preferred
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)
Benefits
Relocation assistance is available for this position at this time.
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
