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Design Quality Engineer III - Interventional Cardiology at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

0.0

Posted On

20 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Assurance, Quality, Medical Device Standards, Risk Management, Design Verification, Design Validation, Usability Protocols, Problem-Solving, Communication, DFMEA, Hazard Analysis, Root Cause Analysis, Design Optimization, Process Validation, Collaboration, Technical Reporting

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Develop, update, and maintain Design History File and Design Input / Output documentation Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. 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 sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Bachelor's degree in an engineering discipline Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience Experience writing specifications, test protocols, and technical reports Demonstrated use of quality tools and methodologies include DFMEA, Hazard Analysis, Root Cause Analysis Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics Strong communication skills (verbal and written). Effectively present complicated technical information to small and large audiences, from peers to senior leadership. Bachelor's degree in mechanical, electrical, or biomedical engineering 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. Experience in design engineering or process development, including design optimization and process validation Adaptable and effective collaborator in a team environment and in self-directed work

Responsibilities

Develop and maintain Design History Files and risk management documentation. Provide design quality support in resolving quality issues and executing verification and validation protocols.