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Quality Engineer I Job

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Date: Apr 6, 2021

Location: Arden Hills, MN, US, 55112

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 This Role:

This Quality Engineer role will investigate product complaints for the Electrophysiology (EP) division of Rhythm Management. The team uses complaint and physical product analysis data to inform cross-functional division of potential safety and quality issues with BSC EP products. This role provides significant visibility across the quality organization. 

 

Your Responsibilities Will Include:

  • Assumes technical role in functional area by using technical expertise and knowledge to support current and new market released technology 
  • Assists Senior level engineers in projects to enhance the ability to perform various complaint Investigations
  • Maintains knowledge of state-of-the-art principles and strategies in their particular area of expertise
  • Participates in technical strategy planning for Boston Scientific
  • Assists lab technicians during complaint/analysis investigaitons to ensure accurate and compliant product analysis and documentation 
  • May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project team comprised of functional experts and local managers
  • Analyze returned products to address complaints and to ensure a high level of product quality
  • Communicate product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Research and Development, Supplier Quality and Manufacturing
  • Participate in cross functional teams to resolve quality issues
  • Interpret complex technical issues for a non-technical audience
  • Provide techical support for regulatory and legal inquiries
  • Assist in developing novel methods to effectively analyze product complaints
  • Performs a variety of duties in the electrical, mechanical, electro-mechanical, chemical, or optical areas

 

What We're Looking For In You:

Minimum Qualifications

  • BS with 0-3 years of relevant experience
  • Understanding and a command of highly technical engineering and mathematic topics
  • Ability to independently manage project work to define delivery dates
  • Understanding and experience operating within quality system processes and procedures.  
  • A successful track record of cross organizational project collaboration
  • Significant participation in the Hazard Analysis and Risk Assessment as related to trend management
  • Strengths in communication (verbal and written) and data analysis skills

Preferred Qualifications

  • Engineering degree with 1-3 years of relevant experience
  • A strong technical understanding of device therapy products
  • Strong Technical Writing skills
  • Experience with the Quality system escalation process including NCEP initiation and escalation into the CAPA and PIR processes. 
  • Strong understanding of the Quality system and post-market complaint tracking, patterning and analysis
  • Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing
  • Ability to work with or independently learn automation tools such as Automation Anywhere is highly desirable.
  • Experience supporting competent authority responses

 

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: 476829

 


Nearest Major Market: Minneapolis

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