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Boston Scientific · 2 days ago

Design Quality Assurance Engineer II - Urology

Marlborough, MA

Full-time

Hybrid

Entry, Mid Level

$75K/yr - $143K/yr

2+ years exp

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 safety, quality, and compliance while continuously improving product value.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Mechanical EngineeringElectrical EngineeringBiomedical EngineeringISO 13485ISO 14971Quality System RegulationsRisk ManagementProblem SolvingCross-functional TeamworkCommunication Skills