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 Systems Engineer, Senior will be responsible for systems-level analysis and design to create complex electromechanical and software medical devices. Responsibilities include assessment of user needs, generation of low-level requirements and risk assessment. The Systems Engineer will lead and/or conduct validation of the medical device. Products will range from software-only medical devices to complex electro-mechanical devices.
What You’ll Do
- On the technical side:
- Assess user needs through user interviews.
- Generate and document system requirements and detailed specifications.
- Design an electro-mechanical architecture to realise the requirements.
- Assemble and test prototype systems in both laboratory and operating room environments.
- Write proper design documentation (DHF) as required by the product development procedure.
- Perform user validation with both internal and external users of the medical devices.
- On the non-technical side:
- Participate in design reviews.
- Work closely with other team members to ensure quality and punctual development.
- Work closely with the Clinical Applications and Technical Publications teams to ensure clear and accurate help and training documentation pertaining to developed system.
- Manage and co-ordinate third-party standards testing.
- Liaison with suppliers, generate RFQs and SOW, as necessary.
- Other related duties as required.
What You’ll Need
- Bachelor’s degree in Systems Design Engineering, Mechatronics Engineering, Biomedical Engineering, or equivalent.
- 1-4 years of experience in systems engineering.
- 1-4 years of experience with SolidWorks.
- Knowledgeable of the following standards: IEC 60601, ISO 13485, ISO 14971.
- Experience in the design, development, and testing of medical devices.
- Experience in risk assessment methodologies.
- Professional or personal experience/interest with video standards and technologies, cameras, etc.
It’d Be Amazing If You Had
- Prior experience with training on use and applications for medical equipment.
- Experience setting up and using Jira to manage defects and requirements.
- Knowledge of different software development methodologies.
- Background in EMC testing and specifications.
- Software development experience.
- Friendly and positive attitude.
- Self-motivated self-starter.
- Ability to thrive in a high energy environment where delivering a safe and complete product is far more important than following your job description to the letter.
- Ability to remain humble.
- Prepared to give and take constructive feedback daily.
- While recognizing that process is your friend, you aren’t afraid to question why something is done a certain way and identify opportunities for improvement when you see them.
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.
We would like to thank everyone who submits a resume for these positions. Due to the volume that we receive, only those candidates selected for interviews will be contacted.
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