Principal R&D Systems Engineer - Electrophysiology

This person will be responsible for leading the design and development of novel integrated solutions for Boston Scientific's rapidly growing and evolving EP product portfolio. The Principal Systems Engineer will be a member of a cross-functional core team.

Responsibilities

• 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
• 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
• 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
• 7+ 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