Design Quality Engineer II

Design Quality Engineer II

Boston Scientific is currently recruiting for a Design Quality Engineer II in our Maple Grove, MN location. This is an exciting opportunity to participate in the quality assurance of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC. The Design Quality Engineer II will support the application of design controls to focusing on new product development and sustaining engineering projects. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.

Your responsibilities will include:

• Works within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Update and maintain risk management files, such as 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.
• Apply judgement to solve problems and determine appropriate action and solutions
• Supports departmental, functional, and divisional design quality goals and priorities.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements

What we're looking for in you: Required qualifications:

• Bachelor's degree in an engineering discipline
• Minimum 3 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.

Preferred qualifications:

• 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