Boston Scientific R&D Principal Systems Engineer - Electrophysiology 

United States, Massachusetts, Waltham 

728945979

The Principal Systems Engineer will be a member of a cross-functional core team. Responsibilities of the Principal Systems Engineer include: leading the development of requirements in close collaboration with marketing and internal and external stakeholders, understanding and analyzing clinical workflows, interfacing with/presenting to medical key opinion leaders, generating systems architectural concepts in collaboration with the technical team, leading and providing guidance to an interdisciplinary team of SW/Electrical/Mechanical professionals, planning test method developments, analyzing data, implementing the solutions in hardware and software according to Boston Scientific’s product development procedures.

Your responsibilities will include:

• You will be responsible for completing system engineering activities, from early phase development to market release. Your key tasks will include:

• Designing or supporting the development of systems architecture aligned with business and customer needs.

• Executing multiple systems engineering activities throughout the product development life cycle.

• Applying critical thinking skills to solve complex systems interaction problems.

• Providing expertise in multiple roles in the product development life cycle, showcasing deep knowledge of system functionality.

• Advising the project management team on key product risk/benefit trade-offs.

• Influencing cross-functional peers to make timely decisions and recommendations for project success.

• Representing the Systems Engineering organization as the prime technical contact for assigned features, tools, or subject matters.

• Providing input for submissions to regulatory bodies and governmental agencies.

• Defining interface requirements between systems and maintaining traceability of requirements documentation.

• Managing changes to interfaces during development and throughout the product lifecycle.

• Ensuring configuration compatibility through the product lifecycle.

Qualifications:

• Bachelor's degree in Engineering and/or Science with 10+ years of experience in developing highly complex systems.

• 5+ years of experience as a Systems Engineer in the medical/diagnostics space, focusing on electromechanical systems.

• Demonstrated working knowledge of systems engineering principles, requirements management, and medical device regulations.

• Ability to lead teams through a structured approach to solving complex technical problems.

• Experience with requirement management, collaboration, and issue tracking tools.

• Experience in product concept development, customer interaction, verification of engineering requirements, and validation of customer needs/design requirements.

• Practical knowledge of project management concepts and experience with Agile concepts including scrums.

• Leadership skills with the capability to make trade-offs between risks, benefits, and performance.

• Understanding and experience in the design, development, and testing of software based medical devices.

• Familiarity with developing Test Methods and Test Equipment.

• Experience with industry-based standards, including testing for safety and EMC according to 60601-1

Preferred Qualifications

• Experience with cyber security and IEC 62304.

• Usability engineering experience.

• Electrophysiology knowledge.

• Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.).

• Experience conducting simulations, mathematical analysis and/or system interaction analysis.

• At least 6 years of engineering experience in mixed HW/SW systems.

• Technical experience with digital and analog low noise systems.

• Strong written and verbal communication, judgment, decision-making, and critical thinking skills.

• Ability to build strong relationships across the organization and with external stakeholders.

“Interested in hearing from a Systems Engineer at Boston Scientific? Check out our video featuring Sanchit to learn more about the role:

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.

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!

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.