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Design Assurance Engineer I Job

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Date: Nov 27, 2020

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

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. Want to know more about what it’s like to work at Boston Scientific? Our “Day in the Life” Zoom series offers an opportunity to interact with employees who are collaborating for change. Copy and paste this link into your browser to sign up: https://bit.ly/bscdayinthelife .


About the role:

The Design Assurance Engineer I is a quality engineer that supports medical device product development from concept through commercialization as a member of the Compliance and Continuous Improvement team.  This position will work with high-performance, cross-functional teams to optimize and maintain quality systems procedures, tools, and guidance that support the execution of Design Control, Risk Management, and Post-Market Surveillance within Interventional Cardiology.  


Your responsibilities will include:

  • Applying sound, systematic problem-solving methodologies to resolve quality issues
  • Acting as an effective team member in supporting quality system processes, decisions, and practices
  • Evaluating quality system procedures and current team practices to ensure they meet internal and external requirements
  • Partnering cross-site to identify and support value improvement efforts to support business goals
  • Helping to maintain a comprehensive Design Control resource website
  • Providing recommendations for updated or new guidance for Design Control, Risk Management, and Post-Market Surveillance
  • Gathering data and metrics information to support larger quality system reviews
  • Supporting post-market surveillance of products through evaluation of data and trends
  • Intermittently working within a cross-functional team to develop, update, and maintain Design History File documentation from concept through commercialization
  • Intermittently updating and maintaining product Risk Management Files (e.g. Hazard Analysis, Fault Tree, FMEAs)


What we’re looking for in you:

Minimum qualifications:

  • Bachelor of Science degree in scientific or 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
  • Experience working within medical device quality systems
  • 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


Boston Scientific maintains a drug-free workplace.  Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 470606


Nearest Major Market: Minneapolis

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