Job Purpose
We are looking for a Senior Systems Engineer to support the development of complex active implantable urology systems.
In this role, you will drive system-level definition, architecture, requirements, and integration activities from concept through commercialization.
The Systems Engineer balances clinical user needs, technical feasibility, risk, and business objectives to ensure a high-quality, compliant product solution across implantable and external system components.
Key Responsibilities
Translate user needs and clinical requirements into system and sub-system requirements across implantable and supporting systems.
Define system architecture, interfaces, and partitioning for active implantable platforms.
Maintain traceability between user needs, system requirements, design outputs, verification, and validation.
Identify and manage system-level risks through hazard analysis, DFMEA, and use-related risk assessments.
Support system integration planning and characterization studies.
Ensure system testability and support development of system-level verification and validation strategies.
Provide systems thinking to assess impact of design changes across the broader system.
Act as the R&D systems representative on cross-functional teams.
Generate and maintain system documentation in alignment with the Quality Management System.
Mentor engineers in systems engineering methodologies and best practices.
Education & Experience
Hons bachelors degree or Masters degree in Engineering (Systems, Electrical, Mechanical, Biomedical, or related field).
5+ years of experience in medical device product development.
Strong experience with requirements management, architecture definition, and systems integration.
Knowledge of design controls, risk management, and V&V processes.
Excellent communication and stakeholder management skills.
Preferred Qualifications & Experience
Experience with active implantable medical device or systems.
Familiarity with Human Factors and Usability Engineering processes.
Experience supporting FDA or notified body interactions.
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative.
It is essential in advancing science for life and improving patient health.
We stand for inclusion, equality, and opportunity for all.
By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability.
Should you require a reasonable accommodation during the recruitment process, please email ******.
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