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.
Software Engineer II - Design Assurance/Quality
About the role:
This position is an opportunity to work for a world wide and diverse company who puts patients first. Through this position, the ideal condidate develops, establishes and maintains quality engineering methodologies, systems, and practices which meet Boston Scientific (BSC), customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering software support within new product development, operational, or system/services support.
Your responsibilities include:
Working within a team of Product Software Quality Assurance Test Engineers (embedded within R&D).
Actively contributing to all aspects of Software and Firmware Quality Assurance activities in an FDA/EUMDR-Regulated Class II Medical Device Softwareenvironment including interconnected software systems.
Support the design, development, and test of software, firmware, and hardware used in Boston Scientific Urology / Pelvic Health product lines during their entire Development Life Cycle, from the Requirements gathering phase to the Retirement phase.
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 risks and Risk Management activities.
Support the creation and execution of validation scripts to perform system level testing of our products and report any issues discovered.
Creation and review of risk management documentation such as, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA).
Contribute to the development of software safety classifications / level of concern rationale.
Creation and review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, Security Assessments etc.
Creation and review of software, mechanical and hardware DQA documentation as required.
Become a Subject Matter Expert (SME) for all firmware and software DQA requirements for the products supported.
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:
BS in Software or Electrical Engineering or related technical degree
Minimum of 3-5 years of software or engineering experience, with preferred experience in Medical Device Softwareand integrating systems (preferred).
MS in Electrical or Software Engineering strongly preferred.
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.
Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485 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.
Travel approximately 10-15% of the time
5+ years of medical device engineering experience preferred with 2+ years’ experience with Software a medical device experience.
Familiarity with IEC 60601 family and EN 62304 preferred
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.