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Software Design Quality Engineer I Job

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Date: Sep 10, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)


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.


Software (SW) Design Quality (DQA) Engineer 1


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, software as a medical device, and cyber security mission 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 SW DQA Engineer 1, 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 and the cyber security mission 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:

  • Learn the Boston Scientific Quality System for New Product Development (21 CFR 820/ ISO13485) and Medical Device Software process (IEC 62304) with focused attention to Cyber security.
  • Engage with 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.
  • Support and work with other Design Quality Engineers to identify risk/vulnerability findings through coordinating with R&D during all phases of Software / Firmware and Cyber Security design using Quality Assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device Software environments (including interconnected software systems).
  • Support the creation and maintain 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. 
  • Support the development and documentation of software safety classifications / level of concern rationale.
  • Support all medical device software documentation including cyber security assessments such as Data Protection, Privacy, Security Assessments etc.
  • Support the creation and/or review of software, mechanical and hardware DQA documentation as required.
  • Participate in Software/Cyber Security Communities of Practice (COP’s).
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support diversity and inclusion of initiatives within the company
  • May perform other duties as directed


What we’re looking for in you:
Minimum Qualifications

  • BS in Electrical or Software Engineering.
  • Minimum of 1 years of Medical device engineering experience, with experience in Medical Device Software, Cyber Security
  • Strong communication and presentation skills.
  • Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent), Linux operating systems, C++.
  • Travel approximately 10-15% of the time

Preferred Qualifications

  • 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 820, is ideal, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, EN IEC 62304 and EN ISO 14971.
  • MS in Electrical or Software Engineering strongly
  • 3+ years of medical device engineering experience preferred with knowledge experience with Software as a Medical Device and Integrating Systems.
  • Understanding of IEC 60601 family




Requisition ID: 487798


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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