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Boston Scientific · 1 day ago

Design Quality Engineer II

Arden Hills, MN

Full-time

Hybrid

Entry, Mid Level

$72K/yr - $136K/yr

2+ years exp

Boston Scientific is a global leader in medical technology, and they are seeking a Design Quality Engineer II to support Design Controls in their EP/CRM Integration projects. This role involves ensuring product quality and compliance during the integration of medical devices, as well as supporting product development from concept through commercialization.

Health CareMedicalMedical Device

No H1B

Responsibilities

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes

Support the verification, validation, and usability testing to meet or exceed internal and external requirements

Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)

Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities

Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input

Partner cross-functionally to identify and support value improvement efforts to support business goals

Qualification

Quality design assuranceDesign ControlsRisk ManagementISO 13485ISO 14971Quality System RegulationsUsability testingCollaborationProblem-solvingDocumentation