Senior Systems Engineer

19 hours ago

Montreal, Quebec, Canada Boston Scientific Full time
About the Role

We are seeking a highly skilled Senior R&D Systems Engineer to join our team at Boston Scientific. As a key member of our R&D team, you will be responsible for developing system architectures and translating user needs into detailed sub-system requirements throughout the product development lifecycle.

As a Senior R&D Systems Engineer, you will contribute to process improvements, conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. You will work closely with cross-functional teams to evaluate and validate systems, drawing on your deep understanding of hardware, software/firmware, and systems engineering.

Responsibilities
  • Develop system architectures for existing and new product developments.
  • Assess feasibility of new technologies prior to a new product development project through research, bench studies, and pre-clinical evaluation.
  • Participate on project teams to translate user needs into design requirements, consisting of system/sub-system specifications.
  • Manage system/sub-system requirements and generate requirements traceability.
  • Contribute to product risk assessment activities and perform Design FMEA's activities.
  • Assist Regulatory with product submissions.
  • Provide expertise and help evaluate the required validation and verification activities in a given project.
  • Perform systems engineering in compliance with Basic Safety & Electromagnetic Compatibility according to Basic Safety for Medical Devices.
  • Work with a cross-functional team and serve as an R&D representative on cross-functional deliverables.
  • 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.
Requirements
  • Bachelor or Masters of Electrical, Biomedical, Mechanical, 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 trade-offs, performance, and redundancy issues.
Preferred Qualifications
  • At least 4 years of experience leading product development teams in a Medical Regulated Environment.
  • Experience in performing FDA Medical Device Submissions.
  • Experience in performing EU MDR Medical Device Submissions.
  • Experience in performing Japan Medical Device Submissions.
  • Understanding of signal processing.
  • Experience in working on medical devices used in electrophysiology such as therapy or diagnostic devices (ablation and mapping systems).
  • 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.

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