Boston Scientific
Principal R&D Systems Engineer - Electrophysiology
Boston Scientific, Waltham, Massachusetts, United States, 02254
Principal R&D Systems Engineer - Electrophysiology
Work mode: Hybrid Onsite Location(s): Waltham, MA, US, 02138 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. We are looking for a seasoned engineer to join our Systems Engineering department within the Electrophysiology Division at Boston Scientific. The Principal Systems Engineer will be a Systems Engineering technical lead on complex product development projects for the Rhythmia Mapping System. 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 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: 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. Requirements: Bachelor's degree in Engineering and/or Science with 10+ years of experience in developing highly complex systems. 8+ 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 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. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. 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! Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Work mode: Hybrid Onsite Location(s): Waltham, MA, US, 02138 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. We are looking for a seasoned engineer to join our Systems Engineering department within the Electrophysiology Division at Boston Scientific. The Principal Systems Engineer will be a Systems Engineering technical lead on complex product development projects for the Rhythmia Mapping System. 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 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: 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. Requirements: Bachelor's degree in Engineering and/or Science with 10+ years of experience in developing highly complex systems. 8+ 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 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. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. 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! Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.