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Design Quality Engineer II at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Problem Solving, Quality Assurance, Design Control, Risk Analysis, Verification, Validation, Usability Testing, Documentation, ISO 13485, ISO 14971, Collaboration, Medical Device, Engineering, Design History File, Component Specifications, Product Specification

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: 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) Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) Minimum of 2 years of experience in Quality design assurance, new product development or related medical device/regulated industry experience Ability to travel up to 10% Quality Integration experience ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Ability to effectively work and collaborate in a mixed onsite + remote environment.

Responsibilities

The Design Quality Engineer II will apply systematic problem-solving methodologies to resolve quality issues and work within a cross-functional team to implement effective controls. They will also support verification, validation, and usability testing to meet internal and external requirements.