Senior Medical Device Project Lead

1 week ago

Mississauga, Ontario, Canada Traferox Technologies Inc. Full time

About Traferox Technologies Inc.

Traferox creates, manufactures and commercializes innovative medical products used to transplant solid organs, employing cutting-edge technologies invented by the surgeon team of the University Health Network (UHN). Our mission is to increase availability of donor organs, improve surgical outcomes, and save patients' lives.

The company's product portfolio includes the TorEx Lung Perfusion System and the X°Port Lung Transport Device. We are seeking an experienced Senior Medical Device Project Lead to join our team and drive projects from initial concept to translation into the clinic and eventual commercialization.

Job Overview:

We are offering a competitive salary in the range of $120,000 - $180,000 per year for this challenging role.

Key Responsibilities:

  • Define user and system requirements for our medical products.
  • Develop high-level architectures to satisfy user requirements and business needs.
  • Create and implement project plans to ensure successful project execution.
  • Lead cross-functional teams consisting of mechanical designers, electrical engineers, and software developers to design, prototype, and test new medical device products.
  • Plan and execute proof-of-concept experiments to demonstrate new designs before incorporating them into product development.
  • Define verification and validation strategies and create plans, including timelines and resource allocation.
  • Coordinate verification and validation tests and conduct tests when necessary.
  • Manage risk management files and usability files.
  • Organize formal design reviews and phase-gate reviews.
  • Coordinate safety and EMC testing of our products.
  • Obtain feedback from clinical users and translate it into new requirements, feature requests, and design issues.
  • Report project status to management.
  • Contribute to submissions to regulatory authorities.
  • Assist with planning, executing, and documenting preclinical and clinical studies using our products.

Requirements:

  • Bachelor of Engineering in Biomedical, Electrical, or Mechanical Engineering.
  • Masters in Science or similar degree is an asset.
  • 5+ years of experience in medical device engineering.
  • Experience with formal design and development methodologies, including requirements management, verification and validation, and engineering change control.
  • Proven track record of managing engineering projects.
  • Experience working in regulated medical device development environments (ISO 13485).
  • Experience with risk management for medical devices (ISO 14971).
  • Knowledge of obtaining FDA regulatory clearance for medical devices (510k or PMA).

Preferred Qualifications:

  • General knowledge of mechanical engineering concepts.
  • General knowledge of electrical engineering concepts, electronic instruments, etc.
  • Knowledge of information technology.
  • High interest in medical technology.
  • Excellent verbal and written communication skills.
  • Ability to interact with various specialists, including surgeons.
  • Independent motivation and drive to achieve results.
  • Ability to work with minimal supervision.

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