Senior 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 Senior 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 Senior Design Assurance 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 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

Requisition ID: 584778

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 prohibited substance 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.

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.

Nearest Major Market: Boston

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