Boston Scientific Senior Systems Engineer - Electrophysiology 

Canada, Quebec, Montreal 

818927560

About the role

The Senior R&D Systems Engineer will work alongside the R&D team to translate user needs into detailed design requirements and manage system specifications throughout the product development lifecycle. You will contribute to process improvements, conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems, drawing on your deep understanding of hardware, software, and systems engineering.

Your responsibilities will include:

• Participates on project teams to translate user needs into design requirements (e.g. hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications.
• Manage system/sub-system requirements and generate requirements traceability.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
• Contributes to software/system risk assessment activities and uses Design FMEA’s activities.
• Assists Regulatory with product submissions.
• Provides expertise and conducts evaluation of validation and verification activities.
• Assists with industry-based standards testing for safety and EMC according to 60601-1.
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.

Required qualifications:

• B.Eng. / BS in Software or Firmware Engineering, or equivalent.
• 4+ years of experience with product development activities in a regulated industry.
• Experience in Systems Engineering and Systems Verification activities.
• Experience with authoring and analyzing requirements.
• Experience in troubleshooting test failures.
• Strong problem-solving skills in a team environment.
• Excellent organizational, communication and collaboration skills.
• Understanding of hardware design and trade-offs, embedded (real-time) software tradeoffs, performance, and redundancy issues.
• Extensive technical knowledge of advanced testing concepts and formal Software and Systems Verification strategies for regulated Software, preferably in the Medical Device Industry.

Preferred qualifications:

• At least 4 years of experience leading product development teams in a Medical Regulated Environment.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Knowledge of ISO 14971.
• Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.

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.