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Senior Quality Engineer Job

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Date: Sep 10, 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:

The Senior Quality Engineer will provide Design Quality support to the Electrophysiology (EP) division to and ensure delivery of the highest quality risk analysis and documentation for EP products.  They will partner across the design teams, medical safety, manufacturing and others to provide risk management information, updates and consultation.  This position may also provide other design quality engineering support as necessary.

 

 

Your responsibilities will include:

  • Owns, creates, maintains and/or supports risk management documents (and related docs) such as Hazard Analysis, DFMEA, Risk Management Plan, Risk Management Report, Clinical Evaluation Reports, etc.
  • Highly cross-functional in nature, this role consults with product experts, post market and medical safety functions and others as needed for risk analysis across the life of BSC EP products.
  • May provide support to Design Quality Engineers which are sustaining and creating product documents for new and changing products.
  • Represents risk in project teams for new and sustaining products.

 

 

What we’re looking for in you:

Minimum Qualifications

  • BS with 5 or more relevant experience or MS with 3 or more years of relevant experience
  • Strong written and verbal communication skills
  • Experience with analytical techniques and statistical analysis
  • Ability to own and drive quality efforts in a cross functional environment.

Preferred Qualifications

  • Demonstrated experience executing in a quality function across multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines
  • Experience executing in cross-functional teams across sites and across the globe and driving deliverables to completion.
  • Experience performing risk analysis activities such as Hazard Analysis, FMEA, Fault Tree Analysis, etc.
  • Knowledge of EP products and their clinical application.
  • Prior interactions with the following disciplines: CAPA, manufacturing engineering, post market complaints, risk management, supplier quality, process engineering
  • Self-starter with the ability to identify improvement opportunities
  • Comfort speaking to groups of individuals; presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences

 

 

 

 

 

 

Requisition ID: 487677

 

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, Senior Quality Engineer, Manufacturing Engineer, Engineering, Quality, Healthcare