R&D Systems Engineer II / Ingénieur II En Systèmes De R Et D

R&D Systems Engineer II / Ingénieur II En Systèmes De R Et D

Work Mode: Hybrid

Onsite Location(s): Montreal, QC, CA

Additional Location(s): Canada-QC-Montreal

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.

About The Position

The R&D Systems Engineer II works with the R&D team to translate user needs into detailed design requirements and manage systems specifications throughout the product development lifecycle. They contribute to process improvements, conduct risk assessments, and support regulatory requests by ensuring compliance with industry standards. This role is expected to work closely with cross-functional teams to evaluate and validate systems using their extensive knowledge of hardware, software, and systems engineering.

Your responsibilities will include:

• Participate in project team activities to translate user requirements into design criteria (i.e. hardware, software, mechanical, electrical, interface, etc.) stated in the form of specifications for systems and subsystems.
• Manage system and subsystem requirements and ensure their traceability using a requirements management tool.
• Participate in the development of system design architectures.
• Document and design communication protocols between different subsystems (software, firmware and FPGA).
• Contribute to product risk management documentation – risk analysis, design FMEA and process FMEA.
• Conduct test bench studies and write technical reports.
• Provide expertise in and carry out validation and verification activities.
• Undertake and document design change assessments for new and supported products.
• Manage and maintain the JIRA backlog and prioritize features to be implemented.
• Participate in the reconciliation of subsystem models and the integration of features at the system level.
• Work within a cross-functional team and represent R&D on cross-functional deliverables.
• Continuously improve processes and working methods (applying Agile/Lean principles to eliminate waste) to contribute to the resolution of complex and interdisciplinary problems, while interfacing with peers and cross-functional groups.
• Have a solid understanding of the medical device industry's design control processes.
• Other duties as required.

Required qualifications:

• University degree in electrical engineering, biomedical engineering or a related field.
• 2+ years of experience in product development within a regulated sector.
• Experience in systems engineering and verification.
• Experience in the areas of requirements writing and analysis.
• Experience in the field of diagnostic testing.
• Excellent problem solving skills in a team environment
• Excellent organizational, communication and collaboration skills

Preferred qualifications:

• At least two years of experience in product development in a regulated medical environment.
• Understanding hardware design and tradeoffs, embedded (real-time) software tradeoffs, performance and redundancy issues.
• Deep technical knowledge of advanced testing concepts and formal software and system verification strategies for regulated software, preferably in the medical device industry.
• Extensive knowledge of ISO 13485 and FDA 21, CFR Part. 820 standards.
• Knowledge of ISO 14971 standard.
• Proven ability to interact and influence key stakeholders, both inside and outside the company.