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Principal Design Quality Engineer at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Feb, 26

Salary

0.0

Posted On

27 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Problem-Solving, Critical Thinking, Data Analysis, Quality Assurance, Quality Tools, Collaboration, Communication, Medical Device Regulation, ISO 13485, ISO 14971, Design Quality, Self-Starter, Multi-Tasking, Presentation Skills, Clinical Trial Support, Cross-Functional Teams

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Participates as a division representative in cross-divisional projects defining the quality system and may advise management of potential improvements to the quality systems and processes Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Supports functional and divisional design quality goals and priorities Bachelor's degree in an Engineering discipline 9+ years of experience in design assurance, quality, or related medical device experience; or Master's degree and 7+ years experience. Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 13485 and ISO 14971 Quality Standards Proven use of Quality tools and methodologies Demonstrated problem-solving, critical thinking, and data analysis capabilities Hands-on approach to product development and qualification Ability to collaborate and influence across multiple, cross-functional teams Strong communication skills (verbal and written) Comfort with self-directed work in addition to collaboration in a team environment Experience with clinical trial support, multi-site teams, and contract manufacturers Self-starter with the ability to identify improvement opportunities Strong ability to successfully multi-task and adapt Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.

Responsibilities

Develop solutions to complex technical problems and participate in cross-divisional projects defining the quality system. Support functional and divisional design quality goals and priorities.