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Principal Quality Engineer Job

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Date: Sep 8, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills

 

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.

 

Principal Design Quality Assurance Engineer


About the Role:
In this critical role, you will provide leadership and focused quality engineering support to the DQA team for a product family within the Core Stone Franchise of Urology.  You will support the sustaining development to ensure the delivery of the highest quality product to the customer and will collaborate with site, divisional and corporate partners.  

 

Your responsibilities include:

  • Providing quality and compliance leadership and coaching for junior DQA engineers. 
  • Able to build consensus and drive issues to closure.
  • Working closely with cross-functional teams in a fast-paced environment to review and provide feedback on project decisions and deliverables
  • Generation and/or review of Quality deliverables including Risk Management, Product Specification, Design Review, Design Validation, Usability , Test Methods, , Labeling.
  • Influencing key project decisions to improve time to market while meeting or exceeding quality goals.
  • Understanding and leadership for post market activities such as review of customer complaints, NCEPS and CAPAs, PMSRs, and PSURs.
  • Identifying opportunities to streamline development processes and improve compliance to internal BSC SOPs and standards
  • Leading or collaborating in PIRs and FA as needed for the product family.
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.  

 

What were looking for in you:
Minimum Qualifications:

  • 10+ years of Medical Device experience 
  • BS in Engineering or related discipline
  • Extensive knowledge of Design Controls and Risk Management
  • Ability to work in a fast paced, dynamic environment
  • Team player
  • High energy problem solver capable of driving items to closure
  • Excellent communication skills

 

Preferred Qualifications:

  • SUD, Capital equipment and/or software development product experience 
  • Familiarity with BSC Quality System
  • Knowledge of 60601, 62304, Software Development Life Cycle, or similar
  • Reliability
  • Systems Engineering – incl CCP
  • Familiarity with BSC Quality System

 

 

 

 

 

Requisition ID: 486996

 

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

Job Segment: Quality Engineer, Medical, Engineer, Risk Management, Engineering, Quality, Healthcare, Finance