Principal Software Quality Engineer

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:
Boston Scientific is a worldwide and diverse company who puts patients first. The Principal Software Quality Engineer will use electrical/software experience to support, develop, establish and maintain risk management and design controls documentation throughout the Software Development Lifecycle (SDLC). Experience in Software as a Medical Device (SaMD), complex Medical Electrical Equipment/Systems (MEE / MES), IEC 62304 or IEC 82304 is preferred.   

Boston Scientific strives to improve the quality of patient care through a strong design and quality culture. As Principal Software Quality Engineer, with focus on Software Quality, you will be at the heart of that mission to develop best-in-class products to bring advanced, safe innovations to patients throughout the world.  
The engineer will also be leading the effort to establish and maintain MEE / MES in partnership with a diverse and high performing team. Come be part of one of Boston Scientific’s Endoscopy division, delivering exciting products that drive meaningful results.

Your responsibilities may include:

• Drive and execute ISO 14971 risk management process, Verification & Validation (V&V) process and support software applications throughout the Software Development Lifecycle (SDLC) per IEC 62304, IEC 82304 or equivalent standard. Relevant activities include but is not limited to risk controls development, assessment and risk mitigations.
• Develop appropriate documentation and testing for regulatory submissions.
• 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 both ISO 14971, IEC 62304 and IEC 82304 principles.
• Provide support in software risk management process throughout software lifecycle. Relevant activities include creation and/or review of documentation (Software Development Plan, software verification and validation, Hazard Analysis, etc).
• Support software verification/validation activities and associated documentation. Relevant activities include participation in test strategy design, development of test plans and test cases.
• Engage with project teams to create and review Hardware/Software systems and identify possible failure modes/risk control opportunities for complex systems, including interconnected and cloud-based software. Relevant activities include but is not limited to review of SW/HW sub-systems (PCBA’s, FPGAs, with and without Firmware, etc.) and identify risk control measures, review of part schematics for identification or risk control measures, recommend updates to design prints or added tests as a result or risks identified.
• Participate in Boston Scientific Communities of Practice (COP’s) to develop global best practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support Diversity, Equity and Inclusion initiatives within the division and organization.

What we’re looking for in you

Required Qualifications

• Bachelor’s degree in electrical engineering, computer science, software engineering, or a related field
• 7 years of medical device engineering experience or other regulated industry experience
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and electrical testing/simulation software
• Travel approximately 5-10% 

Preferred Qualifications

• Understanding and practice of the FDA, ISO and the medical device industry quality requirements associated with product development, design controls, product risk management and usability engineering.
• Experience in one or more of the following areas:
• Experience with Software as a Medical Device (SaMD) and/or systems integration
• Experience in Medical Electrical Equipment/Systems (MEE / MES)
• Experience in IEC 62304 and/or IEC 82304
• Demonstrate ability to execute and complete multiple projects and objectives, work well in a cross-functional team
• Strong communication and presentation skills
   

Requisition ID: 587679

Among other requirements, Boston Scientific