Principal Technical Architect - Software as a Medical Device (SaMD)

About the role :

At the Boston Scientific Interventional Oncology & Embolization (IO&E) franchise within the Peripheral Intervention division, we design devices used by interventional radiologists in minimally invasive image-guided procedures.

Our products include radioembolic beads, cryoablation systems, coils, particles & gels for embolization, as well as catheters and wires.

We have an exciting opportunity on our Therasphere R&D team for a Principal Technical Architect to work in partnership with Marketing, Program Management, IT, Sales, Legal, Regulatory, and other internal stakeholders to shape franchise software strategy and lead digital product development efforts focused on enhancing customer experience.

The ideal candidate will have proven experience in digital product development using waterfall, agilefall, lean and user centered design methodologies in the healthcare space.

If you are a driven individual with a strong product mindset and excellent problem-solving and communication skills, we would love to hear from you.

Your responsibilities will include :

• Work in partnership, as the technical lead to architect, develop and maintain scalable web applications using React for the front-end and implement server-side logic and APIs using Next.js on the back end.
• Develops solutions to complex technical problems by challenging traditional technical assumptions.
• Manage and deploy applications on AWS EKS cloud infrastructure, ensuring high performance and responsiveness.
• Write clean, maintainable, and efficient code that follows industry best practices.
• Troubleshoot, debug, and upgrade existing systems.
• Participate in code reviews to ensure code quality and share knowledge with the team, especially to mentor junior developers.
• Mentor engineering staff, providing technical guidance, and fostering a culture of innovation and collaboration.
• Solicit input from Quality, Regulatory, Design Assurance, Legal, Security and other functions to ensure the franchise delivers compliant Software as a Medical Device (SaMD).
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to ensure Quality System compliance and adherence to the organization’s Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.
• Promote a balanced product development team : integrate and enrich engineering, product design, product management, and data science cultures internally.
• Stay up to date with emerging trends and technologies in web development and about industry trends, emerging technologies and best practices in digital product management and help shape the digital future of the IO&E franchise.

Required qualifications :

• Bachelor’s degree in computer science, Software Engineering, Information Technology, or another relevant discipline
• Experience working in a regulated environment (Medical devices, Pharmaceuticals, Aerospace, automotive industries), ideally including software as a medical device (SaMD) experience.
• 10+ years of demonstrated experience in full stack web application development using Angular / Vue.js / React with a focus on React front-end development over the last 3+ years.
• Proficiency in Next.js and understanding of server-side rendering concepts.
• Expert level knowledge of JavaScript, TypeScript, RESTful APIs, HTML, CSS, DevOps, DevSecOps and significant experience building and maintaining modern CI / CD pipelines.
• Strong knowledge of TDD principles and testing methodologies and Unit Test Frameworks such as Jest.
• Excellent communication and people skills, ability to align stakeholders and develop strong relationships, coach stakeholders that are not digital-savvy and fully leverage their knowledge and support.
• Demonstrated success leading in a team environment to deliver digital products that achieve expected outcomes, and able to coordinate high-quality product releases.
• Strong analytical mindset - understands key impact on customers and stakeholders.

Preferred qualifications :

• Identifies innovative uses of Information Systems to provide a competitive advantage for the organization.
• Drives strategic architecture changes throughout the organization.
• Defines, promotes, and supports the principles and standards of enterprise architecture.
• Architecturally consults and supports multiple large, complex, cross-functional, or divisional projects.
• Champions a policy, process, or technology that delivers significant advances for the IO&E franchise.
• Demonstrates direct methods of influence at the corporate and global level through development of industry recognized publications.
• Recognizes architectural problem areas and determines ways to effectively resolve them.
• Previous experience working in the medical device industry and understanding of FDA, EU MDR, IMDRF regulations.

Requisition ID : 588441

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.

This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.

The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.