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Design Quality Engineer II -Sustaining Job

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Date: Sep 24, 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 Quality Assurance Engineer provides support with high visibility which will provide the right candidate with excellent growth potential.  Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. Products transferred to SE include internally developed systems and Sourced Finished Medical Devices. Sustaining Design Assurance engineer works in close partnership with Research and Development and supporting functions (supplier engineering, operations, post market) focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.


Your responsibilities will include:

  • Proactively investigates, identifies, and implements best-in-class Design Quality Engineering practices.
  • Monitor field performance of recently launched and established medical devices against risk assessments
  • Support Post Market activities such as assessment and or alignment of risk based on post market signals, field assessments.
  • Actively participate on Risk Change assessment process: generate, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
  • Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Interact with software changes for alignment with system level design impact assessments.
  • Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Develop, update, and maintain Design History File and work with RD for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination


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

  • Bachelor’s degree in electrical engineering, computer engineering, or related discipline 
  • 2+ years of experience in design assurance, new product development or related medical device / regulated industry experience
  • Experience with medical electrical systems / electrical medical equipment / capital equipment
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies.
  • Ability to effectively work and collaborate in a remote environment.
  • Experience with medical standards compliance


Requisition ID: 484372


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

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