Senior R&D Systems Engineer

7 days ago


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

We are seeking a highly skilled Senior R&D Systems Engineer to join our team at Boston Scientific Gruppe. 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.

Key Responsibilities
  • Develop system architectures and translate user needs into detailed sub-system requirements
  • Contribute to process improvements (customer experience, manufacturing and servicing)
  • Conduct risk assessments and support regulatory submissions, ensuring compliance with industry standards
  • Collaborate with cross-functional teams to evaluate and validate systems
  • Assess feasibility of new technologies prior to a new product development project
  • Participate on project teams to translate user needs into design requirements
  • 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
Requirements
  • Bachelor or Masters of Electrical, Biomedical, Mechanical or Firmware Engineering, or equivalent
  • 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
  • Experience in working on medical devices used in electrophysiology such as therapy or diagnostic devices
About Boston Scientific Gruppe

Boston Scientific Gruppe is a global leader in medical science, 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.


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