Systems Developer, Senior

at  Synaptive Medical Inc

About Us
Synaptive Medical is a Canadian medical device company, based in downtown Toronto, focused on supporting healthcare professionals and systems in patient diagnosis and treatment. Synaptive’s suite of products include MRI, surgical planning, navigation, and robotic visualization – all of which can be seamlessly combined or used independently in the operating room. The company has a number of opportunities for innovative people to join the team and share in the development of technologies to solve surgical and imaging challenges in patient care.
The Opportunity
The systems developer is a key member of a multi-disciplinary team that seeks to use systems-level thinking to direct and contribute to product development. You’ll have the unique opportunity to become a product expert where you’ll learn how the many subsystems work to create a state-of-the-art medical device. We are looking for someone who is eager to dig in, learn and actively contribute to our team.

What You’ll Do

• Become a subject matter expert on the design, function, and performance of Synaptive’s surgical product lines
• Contribute to system level design of new product and product improvements
• Generate and document system requirements and detailed specifications
• Plan, coordinate and execute risk management activities (e.g., Hazard Analysis) and human factors testing
• Assemble and test of prototype systems
• Assist with transfer to manufacturing activities of new and sustaining product lines (knowledge transfer, documentation transfer, etc.)
• Lead and participate in design reviews, phase reviews, post market trend reviews
• Work closely with other team members and the QA team to ensure quality and punctual development
• 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
• Support the regulatory team in the creation and response to regulatory filings

What You’ll Need

• Bachelor’s degree in Systems Engineering or equivalent
• 5+ years of experience in product development
• 3+ years of experience in a regulated environment

It’d Be Amazing If You Had

• Knowledge of and experience with the following standards: IEC 60601-1, IEC 60601-1-2, ISO 13485, ISO 14971, IEC 62366, IEC 62304
• Experience in the design, development, and testing of medical devices
• Experience in electrical design and development

COVID-19 Considerations
Synaptive has a special duty to take a leadership role in protecting the health and wellbeing of its employees and the public. The COVID-19 vaccines are an important public health measure for mitigating the spread of COVID-19 in the workplace and society. As a condition of employment, the successful candidate will be asked to provide proof of vaccination or a reason protected by legislation why they cannot be vaccinated against COVID-19.
Diversity & Inclusivity
Synaptive is based out of one of the most diverse countries in the world. This includes differences related to race, ethnicity, national origin, gender, gender expression and presentation, sexual orientation, religion, age, ability and socioeconomic status. To us, diversity is one our strongest assets to our organization. We commit ourselves to promoting the recognition and appreciation of our diverse and rich culture. We believe that it is critical to our success to promote freedom of thought and opinion in a respectful environment. The decisions we make are rooted by respectfully considering each other’s thoughts and opinions and by working towards a greater common goal, saving lives.
Accommodation
Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities. We welcome and encourage applications from people with disabilities. If as a qualified job applicant, you request accommodation, Synaptive will consult with you to provide reasonable accommodations according to your specific needs. If you wish to make a request, you will be provided an opportunity if your application is selected to proceed in our hiring process.
How to Apply
Unless otherwise stated, applications will only be considered from candidates eligible to work in Canada, or the country in which they’re applying to, without sponsorship.
If you are interested in this position and can demonstrate that you meet or exceed the requirements defined in the job description, please include #GOBRAIN in the top right corner of your resume and then complete your online application by clicking “Apply Now” and following the prompts.
The successful candidate to this role will be asked to complete background checks, which may include criminal, credit, employment and/or educational checks. All offers of employment are conditional on the receipt of satisfactory results of any applicable background check.
We would like to thank everyone who submits an application. Due to the volume that we receive, only those candidates selected for interviews will be contacted

• Become a subject matter expert on the design, function, and performance of Synaptive’s surgical product lines
• Contribute to system level design of new product and product improvements
• Generate and document system requirements and detailed specifications
• Plan, coordinate and execute risk management activities (e.g., Hazard Analysis) and human factors testing
• Assemble and test of prototype systems
• Assist with transfer to manufacturing activities of new and sustaining product lines (knowledge transfer, documentation transfer, etc.)
• Lead and participate in design reviews, phase reviews, post market trend reviews
• Work closely with other team members and the QA team to ensure quality and punctual development
• 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
• Support the regulatory team in the creation and response to regulatory filing