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Sr Quality Engineer Job

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Date: Jun 11, 2019

Location: Cambridge, MA, US, 02138

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.


Senior Design Quality Assurance Engineer


About the role:

Primary focus will be to support design assurance activities for Rhythmia products. Provides focused quality engineering support within new product development to ensure the delivery of the highest quality product to the customer. 


Your responsibilities include:

Responsible for assuring all Design Control requirements are met by:

 a) Working closely with R&D (Hardware, Systems and SUD), Marketing, and Regulatory teams in a fast-paced environment to review and provide feedback on project decisions and deliverables including Development Plans, Risk Management, V&V Plan, test cases, trace matrix, release notes, labeling, etc. and for project decisions and deliverables (e.g. Product Specification, Design Review, Design V&V, Test Methods, Process Validation, Labeling)

b) Generation of Quality deliverables such as Quality Plans and Field Assessment Plans

c) Providing quality and compliance input and coaching for post market sustaining activities, review of customer complaints, NCEPs and CAPAs.

 d) Working with project teams implement changes to internal BSC SOPs as appropriate.

e)  Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.  


What we’re looking for you:

Minimum Qualifications:

  • 5+ years of Medical Device experience
  • BS in Engineering or related discipline
  • Ability to work in a fast paced, dynamic environment
  • Team player
  • High energy problem solver capable of driving items to closure

Preferred Qualifications:

  • Capital equipment and/or SUD development product experience 
  • Familiarity with BSC Quality System
  • Knowledge of Design Controls and Risk Management
  • Solid background in statistics



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: 447456


Nearest Major Market: Cambridge
Nearest Secondary Market: Boston

Job Segment: Quality Engineer, Medical, Senior Quality Engineer, Engineer, Engineering, Quality, Healthcare