Senior Systems Engineer

Boston Scientific Gruppe; Clonmel; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Diversity & inclusion

Reasonable accommodations

Job summary

Boston Scientific seeks a Senior Systems Engineer to develop complex medical device systems, including active implantable and capital equipment, from concept through launch. You’ll collaborate with cross-functional teams to balance user needs, market opportunities, and business goals.

Responsibilities include translating needs into system requirements, supporting architecture and integration, and guiding risk assessment and design controls within a regulatory framework.

Qualifications

• Honours bachelor’s degree or MSc in electrical, mechanical, biomedical engineering or related field.
• 5+ years of product development experience, preferably in a regulated environment.
• Experience with requirements authoring, design trade-offs, systems integration, risk management and V&V processes.
• Proficiency in technical documentation, risk assessment and design control processes.
• Knowledge of system architectures and design principles.
• Experience using configuration management, test management, requirements management, and issue tracking systems.
• Ability to lead teams through a structured approach to solving complex technical problems.
• Strong knowledge of design controls & risk management practices.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Support acquisition and integration activities for complex capital equipment and active implantable product systems.
• Translate user needs into design requirements (hardware, software, mechanical, electrical, cloud) ensuring system-wide coherence.
• Support system architecture, design and integration of next-gen technologies/products.
• Provide systems thinking perspective for system/sub-system definition.
• Identify technical risks, develop risk burndown plans, and implement phased integration approaches.
• Contribute to studies on improving system quality, usability, and validation.
• Analyze system requirements for testability and traceability, assist test development.
• Support risk assessment activities and Use/Design FMEA’s.
• Assist product design and prototyping for systems and interfaces.
• Collaborate with R&D, regulatory, quality, and project teams; communicate findings to leadership.
• Mentor engineers and build Systems Engineering capability.

Skills

5+ years experience

Requirements management

Systems integration

Risk management

V&V processes

Communication skills

Education

Honours bachelor’s or MSc in engineering

Tools

Configuration management tools

Test management tools

Requirements management tools

Issue tracking systems

Job description

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.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Systems Engineer on a permanent basis to join our team.

About the role:

We are looking for an experienced Senior Systems Engineer to join the Boston Scientific Urology team. In this role, you will contribute technically in developing medical device product systems, including both capital equipment and active implantable, from initial concept through to product launch. Responsibilities also include supporting acquisition and integration activities, providing technical and engineering expertise.

The Systems Engineer considers both business and technical requirements to deliver a quality product that meets user needs. You will collaborate with cross-functional teams to balance user expectations, market opportunities, and business objectives.

In this role, you will lead engineering efforts to develop high quality, complex medical device systems including active implantable products, capital systems, combination medical devices, single use devices and software-only products for market differentiation and growth within Urology franchises.

Your responsibilities will include:

• Support acquisition and integration activities for complex capital equipment and active implantable product systems. Provide due diligence support through technology evaluations, gap assessments and remediation planning including partnership with cross-functional teams. Support systems requirements and design modifications needed for seamless integration of product systems.
• For new product development, work with all stakeholders to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, cloud interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, and system interface requirements to define the system as a whole and all associated sub-systems.
• Support system architecture, design and integration of new or next generation technologies/products (implantable & capital platform eco-systems) under BSC quality system in collaboration with technical/cross-functional stakeholders.
• Provide systems thinking perspective for system/sub-system definition and understand how product changes affect the larger system
• Identify technical risks, develop risk burndown plans, and implement phased system integration approaches, characterization studies to mitigate risk.
• Support special studies on subjects such as improving system quality, usability, system partitioning, trade off assessments etc. by researching and analyzing options for implementation.
• Analyzes system requirements to determine testability, completeness and support system test development, systems characterization, test method development and build traceability.
• Contribute to system risk assessment activities, Use/Design FMEA’s activities.
• Support product/feature design, concept generation and functional prototyping for systems and associated interfaces.
• Act as an R&D representative on cross-functional deliverables.
• Create and support documentation as part of the Product Development Process (PDP) and Quality Management System.
• Collaborate with R&D, regulatory, quality, project management teams for integration activities and communicate findings/recommendations to senior leadership and key stakeholders
• Builds Systems Engineering capability by mentoring engineers in engineering activities/methodologies and domain knowledge.

Required qualifications:

• Hons bachelor’s degree or MSc in electrical engineering, mechanical engineering, biomedical engineering or related field
• 5+ years of experience with product development activities, preferred in a regulated environment.
• Experience with requirements authoring design, trade-off analysis, systems integration, risk management and V&V processes.
• Proficiency in technical documentation, risk assessment and design control processes.
• Knowledge of System Architectures and design principles.
• Experience using configuration management, test management, requirements management, and issue tracking systems.
• Ability to lead teams through a structured approach to solving complex technical problems.
• Strong knowledge of Design Controls & Risk Management practices
• Strong personal credibility & excellent communication skills
• Ability to work cross-functionally and communicate technical insights effectively

Preferred Qualifications & Experience

• Experience leading product development teams in a Medical Regulated Environment.
• Experience in building and modifying System Architectures, Systems Requirements, Systems Design for implantable medical devices and connected platform eco-systems.
• Knowledgeable in Human Factors and Usability Engineering processes as part of regulated product development.
• Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.
• Experience dealing with regulatory questions from FDA, BSI, TUV

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.

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 [e-mail]

Job Segment: Biomedical Engineering, R&D Engineer, Systems Engineer, Medical Device, Cloud, Engineering, Healthcare, Technology