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Design Quality Engineer II at Boston Scientific Corporation Malaysia
Maple Grove, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

28 Jan, 26

Salary

0.0

Posted On

30 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Design History File, Design Verification, Design Validation, Usability Protocols, Quality Support, Problem Solving, Quality System Requirements, Good Documentation Practices, Specifications Writing, Test Protocols, Technical Reports, DFMEA, Hazard Analysis, Root Cause Analysis, CAPA, Medical Device Standards

Industry

Medical Equipment Manufacturing

Description
Your responsibilities will include: Develop, update, and maintain Design History File and Design Input / Output documentation Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply judgement to solve problems and determine appropriate action and solutions Executes methodologies to identify, prioritize, communicate, and resolve quality issues Bachelor's degree in an engineering discipline Minimum of 2 years of experience in design assurance, quality, or related medical device or regulated industry experience Knowledge of basic Quality System Requirements and Good Documentation Practices Experience writing specifications, test protocols, and technical reports Strong communication skills (verbal and written). Effectively organize, present, and explain information to internal audiences. Bachelor's degree in mechanical, electrical, chemical, or biomedical engineering Demonstrated use of quality tools and methodologies including DFMEA, Hazard Analysis, Root Cause Analysis, CAPA Demonstrated ability to solve engineering problems using analysis, experimentation, and statistics Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. Adaptable and effective collaborator in a team environment and in self-directed work
Responsibilities
Develop and maintain Design History File and documentation. Execute Design Verification and Validation protocols to meet requirements.