Design Quality Engineer II

Boston Scientific • Arden Hills, MN

1d

About The Position

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

Requirements

• 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

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees