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Design Quality Engineer II- IC Imaging and Diagnostics Job

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Date: Sep 15, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


Design Quality Engineer II


About the role:
We have an exciting opportunity for an Engineer supporting Imaging and Diagnostics within the Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential.  Work with high-performance cross-functional team to develop and maintain the design controls and risk analysis for a product family and ensure safety, quality and compliance of new and launched products while continuously improving their commercial value. 


Your responsibilities include:

  • Actively promote and participate in a cross-functional teamwork environment.
  • Drive Risk Change Assessment process to update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Participate in the Design Change process to ensure proposed changes to the products are systemically and thoroughly analyzed through the Design Control Process.
  • Lead the development of and coordinate the execution and documentation of Design Validation and Verification activities.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

What we’re looking for in you:
Minimum qualifications:

  • Bachelor’s degree in an Engineering discipline or related field of study
  • 2 years relevant experience
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on approach to product development/improvement
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies.

Preferred qualifications:

  • ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis 
  • Previous development of complex medical device system experience
  • 2-4+ years of experience in design assurance, new product development or related medical device experience


Requisition ID: 497397


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!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


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.


Nearest Major Market: Minneapolis

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