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Senior Quality Engineer Job

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Date: Sep 8, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

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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.


Senior Design Quality Assurance Engineer

About the role:
Primary focus will be to support design assurance activities for Urology Laser products. Provides focused quality engineering support within new product development to ensure the delivery of the highest quality product to the customer.  


Your responsibilities include:
Responsible for assuring all Design Control requirements are met by:
 a) Working closely with R&D (Hardware, Systems and SUD), Marketing, and Regulatory teams in a fast-paced environment to review and provide feedback on project decisions and deliverables including Development Plans, Risk Management, User Needs, system and design requirements and labeling, etc. and for project decisions and deliverables (e.g., Design Review, Design Validation and verification, Test Methods, Process Validation, Labeling)
b) Generation of Quality deliverables such as D&D Plans, Risk management documents, Design Validation and usability..
c) Providing quality and compliance input and coaching for post market sustaining activities, review of customer complaints, NCEPs and CAPAs.
d) Working with project teams implement changes to internal BSC SOPs as appropriate.
e)  Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.  


What we’re looking for you:
Minimum Qualifications

  • 5+ years of Medical Device experience 
  • BS in Engineering or related discipline
  • Ability to work in a fast paced, dynamic environment
  • Team player
  • High energy problem solver capable of driving items to closure


Preferred Qualifications:

  • Capital equipment and/or SUD development product experience 
  • Reliability
  • Systems Engineering – incl CCP
  • 60601 
  • Essential Performance
  • Expected Service Life
  • EMC/EMI (60601-1-2)
  • RED Directive
  • Laser Specific Particular Standards (60601-2-22)
  • Endoscopic devices (60601-2-18)
  • Familiarity with BSC Quality System
  • Knowledge of Design Controls and Risk Management
  • Solid background in statistics





Requisition ID: 486997


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: Boston

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