Systems Engineer, Senior

Job type: Full-Time
Accepting BioReady™: Yes
Category: Research and Development
Education: Bachelor
Experience: 4-6 Years
Employer: Synaptive Medical
Salary:
Location: Toronto, ON
Posted: August 13, 2019
Ends: September 13, 2019

About Us

Synaptive Medical is a Downtown Toronto based company focused on developing medical equipment and applications for neurosurgical procedures. Together, these devices form a full and complete solution of visualization technologies for the operating room. In the past 20 years, the core members of Synaptive Medical have founded and grown multiple successful medical start-ups into international markets. The company has a number of opportunities for motivated people to join the team and share in the challenges and rewards of developing technologies to improve patient care and outcomes in neurosurgery.

The Opportunity 

The systems engineer will be responsible for ensuring Synaptive products are designed such as they operate as expected by the user. This includes generating system requirements, leading risk management activities, planning and coordination of human factors evaluations and creating and maintaining parts of the device history file (DHF) for these products. You will have the opportunity to participate in clinical research and observe surgeries to help develop system requirements. The Systems Engineer is a key member of a multi-disciplinary team that includes mechanical and engineers, software developers, industrial designers, user experience designers, optical designers, scientists and technical writers.

What You’ll Do   

  • Work closely with the hardware and software design teams to generate and document system requirements and detailed specifications for complex electro-mechanical systems
  • Plan, coordinate and execute risk management activities such as the hazard analysis
  • Define system architecture and sub-system interfaces, requirements, and behaviours
  • Plan, coordinate and execute human factors and usability evaluations
  • Collaborate closely with the Systems Test team to support planning and execution of verification and validation activities
  • Perform user validation with both internal and external users of medical devices
  • While working closely with the design teams, assist with the assembly and test of prototype systems
  • Assist with the development of fabrication, assembly, and manufacturing processes of devices
  • Write proper design documentation (DHF) as required by the QA product development procedure
  • Assist with transfer of new and sustaining product lines to manufacturing activities (knowledge transfer, documentation transfer, etc.)
  • Contribute to best practices of systems engineering processes and workflows within the company and across multiple projects
  • Participate in design reviews, phase reviews and post market trend reviews
  • Manage and co-ordinate third-party standards testing (e.g. biocompatibility, safety)
  • Provide guidance on use and application of standards applicable to design projects
  • Liaison with suppliers, generate RFQs and SOW, as necessary
  • Manage subcontractors for some design elements
  • Interpret and implement quality system compliance requirements related to design control
  • Support creation of regulatory filings as required
  • Mentor junior engineers and interns
  • <10% travel to visit customer sites
  • Assist with other tasks, as required

What You’ll Need

  • 5+ years of experience in systems engineering
  • Bachelor of Mechanical, Systems, Electrical, Biomedical Engineering or equivalent degree
  • Knowledge of software and product lifecycles (concept to release)
  • Experience in a regulated environment, preferably medical devices or aerospace industry

It’d Be Amazing If You Had

  • Knowledge of and experience with the following standards: IEC 60601-1, ISO 13485, ISO 14971, IEC 62366, IEC 62304
  • Experience with compilation and management of regulatory submission files (technical files, 510(k)s)

About You

  • Must be able to work closely with the team.
  • Self-motivated and self-managing
  • Ability to work in a highly technical, fast-paced environment
  • Ability to communicate clearly and effectively

The Fine Print

The employee may perform other related duties as necessary to meet the ongoing needs of the organization. Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities.

Apply Now