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Sr. Quality Engineer

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Onsite
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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: 
This role within the Complaint Investigation Site (CIS) team in Marlborough, MA will provide you the technical autonomy you need to drive innovation for the Endoscopy and Urology/Pelvic Health Divisions. This role will assist in developing and refining failure analysis methodologies as a means of advancing comprehensive understanding of product performance to improve patient outcomes.  


This position will identify, analyze, investigate, monitor and document patterns and trends in complaint data. Communicate and educate management, R&D, Design Assurance, Ops Quality, Marketing, Sales and other departments about product performance and escalations.  Ensure that information and insights gained from product investigations and corrective actions is fed back to the R&D, Design Assurance and Marketing organizations as part of the risk management and design input process. 


  • Lead development of methodologies and practices in CIS that will evolve overall capabilities and helps develops tactical approaches to implement team strategies. 
  • Perform testing, in a laboratory setting, on returned medical devices associated with customer complaints to determine the most probable cause of the complaint, while ensuring timely closure. Documenting the product investigation activities clearly and accurately. 
  • Analyze customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary and working on cross-functional teams.
  • Provide direction and guidance for assigned tasks to meet department goals and objectives, ensuring that investigations applicable to product complaints and related records within the Global Complaints Management System are robust, with insightful conclusions that support product performance improvements.
  • Communicate product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
  • Provide direction, coaching, and mentoring to engineering and/or technical team personnel. 


What We're Looking For:

Minimum Qualifications

  • BS in Mechanical, Electrical, or Biomedical Engineering, or related discipline   
  • 5+  years of relevant experience
  • Strong communication and presentation skills (Verbal and Written).
  • High energy problem solver capable of driving items to closure

Preferred Qualifications

  • Understanding of external regulations FDA CFR 820, ISO 13485
  • Experience with Design Controls and Risk Management
  • Experience with Advanced Analytics (i.e. Tableau and/or Power BI)
  • Ability to analyze complex data sets using statistical and engineering tools and communicate results to broad range of audience. 
  • Ability to apply engineering essentials to quality investigations to drive to root cause understanding and effective solutions.


Requisition ID: 538511


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.


Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Nearest Major Market: Boston

Job Segment: Senior Quality Engineer, Biomedical Engineering, Quality Engineer, Medical Device, Urology, Engineering, Healthcare

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