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Principal Software Quality Engineer Job

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Date: Apr 6, 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.

Principle Software (SW) Design Quality (DQA) Engineer

About the role:

Boston Scientific is a world wide and diverse company who puts patients first. Through this position, the ideal condidate would use their software experience to lead, develop, establish and maintain medical device software and software as a medical device for new product development (NPD) within the Urology Division of Boston Scientific (BSC).


Our team is all about building the future of the operating room for urologists.  As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives.  As a Principle SW DQA Engineer, you’ll be at the heart of that mission to develop best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort to establish and maintain software as a medical device for new product development (NPD) in partnership with the greatest minds in the entire medical device industry. Your contributions will be directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.

Your responsibilities include:

  • Influence the Urology / PH Division and lead the DQA project team by working with Product Software Engineers (embedded within R&D) to review code, software architecture and identify possible failure modes/risk control opportunities/security vulnerabilities for complex systems with embedded software.
  • Own the investigation to define and integrate risk/vulnerability findings by coordinating with R&D through all phases of Software / Firmware design using Quality Assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device Software environments (including interconnected software systems).
  • Participate in software design reviews with focus on unit test, regression tests, test automation, software architecture, cybersecurity, SOUP evaluation and other areas of related to software and cyber security risks to support Risk Management activities.
  • Support the creation and execution of validation scripts to perform system level testing of our products and report any issues discovered.
  • Own the risk management and usability documentation such as, Hazard Analysis, Design Failure Mode and Effects Analysis (DFMEA), Task Analysis and Fault Tree Analysis (FTA) incorporating software/firmware and vulnerability findings. 
  • Create and/or review of software, mechanical and hardware DQA documentation as required.
  • Own the development and documentation of software safety classifications / level of concern rationale.
  • Become the Divisional Subject Matter Expert (SME) for all software/firmware subjects for the products supported.  
  • Participate in Software/Cyber Security Communities of Practice (COP’s).
  • Lead efforts for Knowledge Sharing or Procedure writing for Software Risk Management Practices.
  • Support all aspects of DQA activities during internal and external audits, as needed.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • May perform other duties as directed


What we’re looking for in you:

Minimum Qualifications

  • BS in Electrical or Software Engineering.
  • Minimum of 7 years of Medical device engineering experience, with experience in Medical Device Software and Integrating Systems or 10 years in a related Industry with relevant Software / System Integration experience.
  • Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software.
  • Working knowledge of US and International regulations including 21 CFR part 820, is ideal, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, EN IEC 62304 and EN ISO 14971.
  • Strong communication and presentation skills.
  • Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent), Linux operating systems, C++, JIRA
  • Travel approximately 10-15% of the time


Preferred Qualifications

  • MS in Electrical or Software Engineering strongly preferred. 
  • 7 years of medical device engineering experience preferred with 3+ years’ experience with Software as a Medical Device and Integrating Systems.
  • Proficient understanding of EN IEC 62304 family preferred
  • Understanding of IEC 60601 family preferred

Requisition ID: 477502


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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