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Design Assurance Engineer II-Compliance and Continuous Improvement Job

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Date: Jun 10, 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.


About the role:
The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization.  Design Assurance engineers work with high-performance cross-functional team members to establish and maintain the design control deliverables, risk management activities, and DHF compliance within Interventional Cardiology to ensure delivery of the highest quality product to the customer.  Specifically, this engineer will join our Compliance and Continuous Improvement (CCI) team to support and improve the quality systems and practices used by our teams rather than execute design control activities for a product. This engineer gathers information, plans, and implements continuous improvement initiatives in the areas of Design Controls, Risk Management, and Post Market Surveillance.

 

Your responsibilities will include:

  • Actively participates in a cross-functional environment and acts as an effective team member in supporting quality disciplines, decisions, and practices. 
  • Apply sound, systematic problem-solving methodologies while identifying, prioritizing, communicating, and resolving quality issues. 
  • Successfully navigates in grey spaces with CCI team and provides logical and creative guidance to cross-functional team members in the application of the Design Control, Risk Management, and Post-Market Surveillance requirements to their products through formal classroom training, wiki content, and team & individual meetings. 
  • Evaluates quality system procedures and current team practices to ensure they meet internal and external requirements. Provides recommendations for updated or new guidance for Design Control, Risk Management, and Post-Market Surveillance.
  • Supports divisional implementation strategy for changes within the quality system, including updating and maintaining communication, implementation plans, and training. 
  • Demonstrates good working knowledge and application of regulatory requirements and internal expectations in areas such as Design Inputs, Design Verification & Validation, Design Review, Design Change, Usability Engineering, Risk Management, and Post-Market Surveillance.
  • Intermittently works within a cross-functional team to develop, update, and maintain Design History File documentation and Product Risk Management Files from concept through commercialization
  • Gathers data and metrics information to support larger quality system reviews 
  • Works with internal customers who represent related and interconnected processes such as Management Review, Design Controls, Risk Management, Cybersecurity, Production and Process Control, Clinical, Medical Safety, Regulatory, and Complaint handling.  

 

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

  • Bachelor of Science degree in engineering related field
  • 2-4 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
  • 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
  • Experience working with cross-functional groups 

 

Requisition ID: 480574

 

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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