Software/Cybersecurity Design Quality Assurance Engineer I Job

Onsite Location(s): US

Additional Location(s): US-MA-Marlborough

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.

Software/Cybersecurity Design Quality Assurance Engineer I

About the role:

Boston Scientific is a worldwide and diverse company who puts patients first. 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 Software and Cybersecurity Design Quality Assurance (DQA) Engineer I, 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 supporting the effort to establish and maintain medical electrical systems (MES) products in partnership with the greatest minds in the entire medical device industry. Your contributions will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.

Your responsibilities include:

• Learn and identify risk based requirements within the Boston Scientific Quality System (21 CFR 820/ ISO13485) for the Medical Device software process, IEC 62304.
• Learn and identify risk based requirements within the Boston Scientific Quality System for Cyber Security Risk Assessment and relevant processes, including Threat Modeling.
• Engage with DQA project teams by working with Product Development Engineers (embedded within R&D) to create / review Hardware/Software systems including Cyber security and identify possible failure modes/risk control opportunities for these complex systems (FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected and cloud-based software systems)
• Participate in the creation 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 IEC 62304 and Cybersecurity principles.
• Participate in the creation and/or review of Software and Cybersecurity documentation
• Participate in DQA Communities of Practice (COP’s) in order to develop global best practices
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Support diversity and inclusion of initiatives within the divisions and organization

What we’re looking for in you:

Minimum Qualifications:

• Minimum of a bachelor’s degree in electrical engineering, computer science, software engineering, mathematics/actuarial science, or a related field
• Familiarity with C/C++ and other programming languages (object-oriented and functional)
• Ability to travel up 15% as needed

 Preferred Qualifications:

• Master’s degree in electrical engineering, computer science, software engineering, mathematics/actuarial science, or a related field
• Medical device engineering experience with knowledge of Medical Electrical Systems and Integrating Systems
• Understanding and practice of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management and usability engineering
• Working knowledge of US and International regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, IEC 62304 and EN ISO 14971
• Experience using Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and Software development / risk management software
• Experience with Threat Modeling
• Strong communication and presentation skills

Requisition ID: 526840

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 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.

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.