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Senior Software Quality Engineer Job

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Date: Feb 19, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minnetonka



Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.



Sr 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, 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 Sr 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 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:

  • 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.
  • Integrate risk/vulnerability findings by coordinating with R&D through 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).
  • 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.
  • Create 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. 
  • Own the development and documentation of software safety classifications / level of concern rationale.
  • Create and/or review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, Security Assessments etc.
  • Create and/or review of software, mechanical and hardware DQA documentation as required.
  • Become a Subject Matter Expert (SME) for all software/firmware and cyber security subjects for the products supported.  
  • Participate in Software/Cyber Security Communities of Practice (COP’s).
  • 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 5 years of Medical device engineering experience, with experience in Medical Device Software, Cyber Security and Integrating Systems.
  • 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++.
  • Travel approximately 10-15% of the time


Preferred Qualifications

  • MS in Electrical or Software Engineering strongly preferred. 
  • 5+ years of medical device engineering experience preferred with 2+ years’ experience with Software as a Medical Device and Integrating Systems.
  • Understanding of IEC 60601 family preferred


About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran


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.

Requisition ID: 472939


Nearest Major Market: Boston

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