Lead R&D Systems Engineer, Electrophysiology

Boston Scientific; Waltham (MA); On-site; USD 107,000 - 203,000; Full time

Job summary

Boston Scientific is seeking a Principal Systems Engineer to lead the EP product development for the OPAL Mapping System. You will guide system architecture, collaborate with marketing and clinicians, and drive requirements across hardware and software domains.

As a technical lead, you will mentor an interdisciplinary team, define test methods, analyze data, and ensure regulatory compliance throughout the lifecycle of complex medical devices.

Qualifications

• Bachelor’s degree in Engineering/Science with 10 years of experience developing highly complex systems.
• 7 years as Systems Engineer in the medical/diagnostics space focusing on electromechanical systems.
• Demonstrated 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 requirements management, collaboration, and issue tracking tools.
• Experience in product concept development, 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.

Responsibilities

• Complete system engineering activities from early phase development to market release.
• 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 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.

Skills

Systems engineering

Requirements management

Medical device regulations

Leadership

Agile (scrums)

Product concept development

Verification & validation

Project management

Software/hardware integration

Education

Bachelor’s degree in Engineering/Science

Tools

Agile tools

Requirements management tools

Job description

Boston Scientific is seeking a Principal Systems Engineer to lead the EP product development for the OPAL Mapping System. You will guide system architecture, collaborate with marketing and clinicians, and drive requirements across hardware and software domains.

As a technical lead, you will mentor an interdisciplinary team, define test methods, analyze data, and ensure regulatory compliance throughout the lifecycle of complex medical devices.