Principal Systems Engineer (Console System)

Boston Scientific; Carlsbad (CA); On-site; USD 106,800 - 202,900; Full time

Job summary

Boston Scientific is seeking a Principal Systems Engineer to lead the development, integration, and commercialization of the next-generation IVL platform within the ICVT division. You will drive system architecture, requirements, interfaces, and verification across capital equipment, embedded software, optics, and catheter-based disposable devices.

The role requires deep engineering principles, medical device development experience, and the ability to influence technical direction across

Qualifications

• Bachelor's degree in Engineering or related technical discipline required.
• 7+ years of engineering experience involving technology development, product development, or complex system development activities.
• 5+ years of technical leadership experience on cross-functional engineering teams.
• Experience in systems engineering of multidisciplinary products involving hardware and software integration.
• Demonstrated expertise in requirements development, systems architecture, interface management, verification, validation, and traceability.
• Experience with Class II/III medical devices and Design Controls.
• Experience with requirements management tools such as Jama, DOORS, Jira, or similar platforms.

Responsibilities

• Serve as technical lead for complex system development activities supporting IVL platform development, guiding architecture, requirements, integration and verification.
• Define, develop, and maintain system requirements, architecture, interface specifications, performance and usability requirements.
• Lead requirements decomposition and traceability from user needs to subsystem requirements, design outputs, verification, and validation.
• Drive integration of the complete IVL system across hardware, embedded software, application software, optical and laser subsystems, and disposable devices.
• Define and manage interfaces to ensure seamless system functionality and performance.
• Lead system-level trade studies, simulations, and modeling to reduce program risk.
• Develop system performance characterization methods, measurement methodologies, acceptance criteria, and test strategies.
• Plan, execute, and document integration, verification, validation, and system characterization testing.
• Conduct root cause analysis and drive resolution of cross-disciplinary technical issues.
• Collaborate with software, hardware, electrical, mechanical, optical, quality, regulatory, and clinical teams to ensure alignment with requirements.

Skills

Systems engineering

Requirements development

Cross-functional leadership

Regulated medical devices

Hardware–software integration

Design Controls

ECOs/CAPAs

Jama/DOORS/Jira

Education

Bachelor’s degree in Engineering or related field

Advanced degree (MS) in Systems/Electrical/Biomedical Engineering

Tools

MATLAB

LabVIEW

Job description

Additional Location(s): US-MN-Arden Hills; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, we 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 help you advance your skills and career. Here you’ll be supported in progressing – whatever your ambitions.

About the role

The Principal Systems Engineer will provide technical leadership for the development, integration, and commercialization of Boston Scientific’s next-generation Intravascular Lithotripsy (IVL) platform within the Interventional Cardiology and Vascular Therapies (ICVT) division. This role is responsible for driving system architecture, requirements development, integration strategy, system verification, and cross‑functional execution across a complex medical device ecosystem consisting of capital equipment (console/generator), embedded and application software, laser and optical subsystems, and catheter-based disposable devices.

As a senior technical contributor, you will serve as a key technical leader responsible for translating clinical and user needs into system‑level requirements, interfaces, architectures, and verification strategies. You will drive technical decisions across hardware, software, mechanical, electrical, optical, and disposable subsystems while ensuring system performance, usability, reliability, safety, and regulatory compliance. You will work closely with engineering, quality, regulatory, clinical, manufacturing, and program management teams to deliver innovative Class II and Class III medical devices from concept through commercialization.

This role requires a deep understanding of engineering principles, medical device development, electromechanical systems, design controls, and the interface between reusable capital equipment and single‑use disposable devices. The ideal candidate will possess strong analytical capabilities, hands‑on development experience, and the ability to influence technical direction across multiple cross‑functional teams.

Work Mode

This role is onsite, requiring employees to work from the local office to support hands‑on system integration, test execution, and cross‑functional collaboration.

Relocation

Relocation assistance is not available for this position at this time.

Visa Sponsorship

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include

• Serve as technical lead for complex system development activities supporting Boston Scientific’s IVL platform, guiding system architecture, requirements, integration, and verification efforts.
• Define, develop, and maintain system requirements, system architecture, interface specifications, system performance requirements, and usability requirements.
• Lead requirements decomposition and traceability activities from user needs through subsystem requirements, design outputs, verification, and validation.
• Drive integration of the complete IVL system across console hardware, embedded software, application software, optical and laser subsystems, and catheter-based disposable devices.
• Define and manage interfaces between hardware, software, electrical, optical, mechanical, and disposable subsystems to ensure seamless system functionality and performance.
• Lead system‑level trade studies, feasibility assessments, simulations, and modeling activities to evaluate design concepts and reduce program risk.
• Develop system performance characterization methods, measurement methodologies, acceptance criteria, and system‑level test strategies.
• Plan, execute, and document integration testing, verification testing, validation testing, and system characterization activities.
• Conduct root cause analysis and drive resolution of complex technical issues spanning multiple engineering disciplines and subsystems.
• Collaborate with software, hardware, electrical, mechanical, optical, quality, regulatory, and clinical teams to ensure alignment with system requirements and development objectives.
• Lead technical reviews and provide guidance to cross‑functional product and technology teams.
• Support project planning and technical risk management activities, identifying critical technical challenges early and driving mitigation actions.
• Develop and maintain system documentation, technical reports, engineering analyses, requirements specifications, interface documentation, and design documentation.
• Support Design Controls activities including risk management, engineering change orders (ECOs), CAPAs, requirements management, and design reviews.
• Contribute technical expertise to regulatory submissions, engineering justifications, responses to regulatory authority questions, and product lifecycle activities.
• Support compliance with applicable medical device standards and regulations, including electrical safety and system‑level design considerations.
• Act as a technical mentor and provide guidance to engineers across disciplines while advancing systems engineering best practices across the organization.
• Build strong collaboration across cross‑functional and multi‑site teams to enable effective execution and successful product delivery.
• Travel up to approximately 10‑20% to support development activities, testing, supplier interactions, and cross‑site collaboration.

Required qualifications

• Bachelor’s degree in Engineering or related technical discipline (or equivalent experience).
• 7+ years of engineering experience involving technology development, product development, or complex system development activities.
• 5+ years of technical leadership experience on cross‑functional engineering teams.
• 5+ years of experience in systems engineering of multidisciplinary products involving hardware and software integration.
• Demonstrated expertise in requirements development, systems architecture, interface management, verification, validation, and traceability.
• Experience developing and supporting Class II and/or Class III medical devices.
• Experience working within regulated development environments utilizing Design Controls and quality system requirements.
• Familiarity with engineering change orders (ECOs), CAPAs, requirements management, and technical documentation.
• Experience with requirements management tools such as Jama, DOORS, Requisite Pro, Jira, or similar platforms.
• Strong analytical, systems‑thinking, and problem‑solving capabilities.
• Excellent written and verbal communication skills with the ability to communicate complex technical concepts across diverse audiences.
• Proven ability to lead technical discussions, influence design decisions, and drive cross‑functional alignment.

Preferred qualifications

• Advanced degree (MS or equivalent) in Systems Engineering, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Software Engineering, or related discipline.
• Experience developing capital medical equipment and disposable catheter‑based therapies as an integrated medical device system.
• Experience supporting PMA and/or 510(k) submissions.
• Knowledge of medical electrical standards such as IEC 60601. The reference Principal Systems Engineer qualifications specifically identify IEC 60601 knowledge as preferred.
• Familiarity with communication protocols such as Ethernet, RS232, SPI, I2C, CAN, or similar technologies.
• Experience with MATLAB, Python, LabVIEW, Minitab, or similar analysis and modeling tools.
• Experience developing system models, simulations, algorithms, and feasibility studies.
• Experience with Agile product development methodologies.
• Experience integrating software, electrical, mechanical, optical, and disposable device technologies into a unified medical device platform.
• Familiarity with risk management methodologies and standards such as ISO 14971.
• Experience working across global or multi‑site engineering teams.

Requisition ID:631638

Minimum Salary: $106,800

Maximum Salary: $202,900

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high‑performance solutions that address unmet patient needs and reduce the cost of healthcare.

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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

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.