Design Quality Engineer III at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design History File, Risk Management, Design Verification, Design Validation, Usability Protocols, Problem-Solving Methodologies, Specifications Writing, Test Protocols, Technical Reports, DFMEA, Hazard Analysis, Root Cause Analysis, Communication Skills, Medical Device Standards Compliance, Process Validation, Design Optimization

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 5+ years of experience in design assurance, quality, or related medical device or regulated industry experience Experience with post-market quality, including returned product analysis and corrective and preventive action (CAPA) 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, process validation, and sustaining engineering Adaptable and effective collaborator in a team environment and in self-directed work

Responsibilities

The Design Quality Engineer III will develop and maintain documentation related to design history and risk management, as well as execute design verification and validation protocols. They will also provide support in resolving quality issues and apply systematic problem-solving methodologies.