Boston Scientific Senior Software Quality Engineer 

United States, Massachusetts, Marlborough 

942155163

Your responsibilities 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:

• Minimum of a bachelor’s degree in electrical engineering, computer science, software engineering, or a related field
• Minimum of 5 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

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.