Quality Design Assurance Engineer II - Electrophysiology

at  Boston Scientific Corporation

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in mechanical, electrical, or biomedical engineering, or equivalent.
• 3+ years of work experience relating to quality assurance in a highly regulated industry.
• Medical device experience
• Competent with use of Microsoft Office Suite

PREFERRED QUALIFICATIONS:

• Focus on detailed work with emphasis on accuracy and completeness
• Excellent organizational and planning skills; drives for results
• Strong communication (oral and written) and presentation skills
• High energy problem solver capable of driving items to closure
• Ability to collaborate and work on a global team
  Requisition ID: 591767
  As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
  So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
  Job Segment: Medical Device, Biomedical Engineering, Medical Device Engineer, Quality Engineer, Compliance, Healthcare, Engineering, Lega

ABOUT THE ROLE:

The Design Quality Assurance Engineer II individual provides quality engineering support to new product development projects and sustaining projects for current products on the market. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Provide quality and compliance input for post market product sustaining activities, such as design changes, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.