Position Type: Full-time

Company Name: 7D Surgical

Position Location: Toronto

Application Deadline: 2014-08-25

Position Overview:

7D Surgical, Toronto, ON, Canada
www.7dsurgical.com

Company Description:

7D Surgical is a Toronto-based medical device start-up company. We are developing the next generation of surgical navigation technologies that directly addresses major pain points associated with current systems: their difficulty of use, and lengthy setup time. We are looking for creative self-motivated team players who thrive in a fast-paced environment and are up to the challenges of bringing innovative medical devices to market.

Job Overview:

You will provide overall project management including the development of detailed work plans to ensure all tasks are completed in a timely manner and the company’s projects are delivered on schedule. You will engage with contract manufacturers and software developers to identify and manage the proper sequence of activities needed to successfully bring our products to market.

Responsibilities:

  • Primary responsibility is timely and predictable delivery of 7D Surgical’s navigation package
  • Develop and implement detailed project plan
  • Manage design control deliverables at design phase reviews
  • Ensure timely and predictable detailed engineering design and development, including design reviews, that result in successful design verification and regulatory submissions
  • Manage external engineering services and contract manufacturers effectively
  • Maintain the DHF and DMR for products
  • Manage transfer of system design to production
  • Interface and work closely with clinical, regulatory affairs, legal and other in-house departments to support regulatory submissions, project planning, and overall corporate goals
  • Coordinate with cross-site teams, including clinical, engineering, and R&D for successful new product introduction and management of product life cycle

Qualifications:

Required

  • Bachelor’s degree in systems or electrical and computer engineering or equivalent
  • Experience managing projects involving hardware/software integration internal to the company and with third parties
  • 10+ years of experience with medical device product development
  • In-depth knowledge of design controls (QSR, ISO 13485)
  • Knowledge of Microsoft Project
  • Ability to train, teach and lead others

Beneficial

  • Experience with surgical navigation, computer assisted surgery, or related fields

Interpersonal Skills:

  • Self-motivated and self-managing
  • Ability to work both independently and on a team
  • Ability to communicate clearly and effectively
  • Attention to details

How to Apply:

Please send your resume to careers@7dsurgical.com with the job title in the subject line.