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Quality Engineer II Job

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Date: Apr 30, 2021

Location: Arden Hills, MN, US, 55112

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 this role:

This Quality Engineer role will investigate and monitor 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, helping to ensure delivery of highest quality product to the customer. This engineer will have an opportunity to participate in standing-up new analytical tools and harmonization of post-market Trending and Analysis practices across BSC business units. This role provides for 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 investigations to ensure accurate and compliant product analysis and documentation
  • Will 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
  • Analyzes customer complaints, returned products, events, and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
  • Perform physical product analysis to identify probable cause of the failure
  • 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 2-5 years of relevant experience
  • Understanding and a command of highly technical engineering 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
  • Critical thinking, problem solving, and troubleshooting ability.
  • Strong communication (verbal and written) and data analysis skills

Preferred Qualifications

  • Engineering degree with 3-7 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

 

 

 

 

 

 

Requisition ID: 477201

 

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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