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Design Assurance Engineer I Job

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Date: Jan 10, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role:

Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provides focused quality engineering support within Interventional Cardiology to ensure the ongoing delivery of the highest quality product to the customer.

 

Your responsibilities will include:

  • Apply sound, systematic problem-solving methodologies using defined business systems (CAPA) to identify, prioritize, communicate, and resolve quality issues
  • Act as an effective team member in supporting quality disciplines, decisions, and practices
  • Execute in streamlined business systems to effectively identify and resolve quality issues
  • Monitor field performance of recently launched and established medical devices against risk assessments
  • Work within a cross-functional team to identify and implement effective controls and support changes to commercialized products to meet or exceed internal and external requirements
  • Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements
  • Partner cross-functionally to identify and support value improvement efforts to support business goals
  • Support post market surveillance of products through competent authority communication
  • Update and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)

 

What we’re looking for in you:

Minimum Qualifications: 

  • Bachelor of Science degree in engineering related field
  • 0-2 years of Engineer related work experience or internship
  • Strong communication skills (verbal & written)

Preferred Qualifications:

  • Prior medical device industry experience
  • Demonstrated use of Quality tools/methodologies
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
  • Problem solver with the knowledge of problem solving tools, capable of facilitating the problem-solving process
  • Adaptable and effective collaborator in a team environment or in self-directed work
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on and solution driven approach to problem solving

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 440580

 


Nearest Major Market: Minneapolis

Job Segment: Engineer, Medical, Intern, CAPA, Design Engineer, Engineering, Healthcare, Management, Entry Level