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Senior Systems Engineer

2 months ago

Montreal, Quebec, Canada Boston Scientific Gruppe Full time

About the Role

The Senior Systems Engineer will play a key role in driving the development of innovative medical devices at Boston Scientific Gruppe. As a leader in medical science, we are committed to solving the challenges that matter most – united by a deep caring for human life.

Key Responsibilities

  • Assess the feasibility of new technologies prior to a new product development project through research, bench studies, and pre-clinical evaluation.
  • Translate user needs into design requirements, working closely with cross-functional teams to evaluate and validate systems.
  • Contribute to product risk assessment activities and perform Design FMEA's.
  • Assist Regulatory with product submissions, ensuring compliance with industry standards.
  • 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.
  • Continuously improve processes and work methodologies, using agile/lean principles to eliminate waste and solve complex, interdisciplinary problems.

Requirements

  • Bachelor or Masters of Electrical, Biomedical, Mechanical, or Firmware Engineering, or equivalent.
  • Experience in Systems Engineering and Systems Verification activities.
  • Experience in troubleshooting test failures.
  • Understanding of hardware design and trade-offs, embedded (real-time) software trade-offs, performance, and redundancy issues.
  • 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 (ablation and mapping systems).

About Boston Scientific Gruppe

We are a global leader in medical science, committed to advancing science for life and improving patient health. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Equal Opportunity Employer

Boston Scientific Gruppe is proud to be an equal opportunity and affirmative action employer, committed to inclusion, equality, and opportunity for all. We maintain a prohibited substance-free workplace and prohibit the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana in the workplace.