
01 Mar Product Compliance and Test Specialist
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
Testing at Synaptive is no run of the mill testing job. Our complex systems are composed of electrical, mechanical, optical and software components.
We are looking for an experienced product Safety, EMC Test Specialist. The successful candidate will have the opportunity to be part of a medical device System Test team tasked with carrying out verification and validation of activities for our world class surgical and diagnostic imaging products. You’ll work closely with our engineering department to plan, schedule and oversee all testing activities with our external certification agencies for the purpose of meeting the requirements for our medical device equipment. In addition, you will contribute to design changes, documentation, and labeling activities that are required to bring our products into compliance.
What You’ll Do
- Support external certification testing for EMC, Safety and Packaging Testing on a variety of products
- Complete internal technical reports and documentation for certification to the appropriate standards
- Be a contact person, on-site if required, between external test houses to facilitate test bookings and answer technical questions pertaining to the product
- Demonstrate the ability to consistently manage multiple projects concurrently
- Gain and maintain a high level of understanding of all required standards, such that pre-scans and informal runs can be conducted prior to certification scans
- Take ownership of various verification and validation (V&V) activities throughout all stages of product development
- Work closely with the development team to understand system design in order to effectively design, develop, and execute test protocols
- Complete documentation for test protocols, results, and reports
- Use exploratory test techniques to provide early testing feedback throughout the design and development process
- Accurately report and track product defects; verify bug fixes while ensuring other areas of product
- functionality aren’t compromised
- Investigate customer issues as needed, to perform root cause analysis and evaluate solutions
- Assist with the development of production/service processes (e.g. writing work instructions, deployment procedures)
- Work closely with multiple teams to ensure quality and timely product delivery
- Assist with other in-house test activities as needed
What You’ll Need
- A minimum of 5 years of relevant experience
- Bachelor’s degree in Electrical Engineering or C.E.T Electronics Technician
- Professional testing experience in an engineering environment focused on new product development or in a test house
- Ability to read and understand electrical drawings and schematics
- Ability to review agency reports and ensure that required changes needed for compliance are incorporated into the product design and product
- A strong foundation in computers and technology, including power user command of Windows OS
- A valid drivers’ license
It’d Be Amazing If You Had
- Experience in the design, development, and testing of medical devices
- Experience with the medical device product development lifecycle
- Former experience working at an agency test house in a similar capacity
- Knowledge of any of the following standards: IEC 60601, ISO 13485, ISO 14971s, ISTA
- Experience with medical devices, robotics, optical components or optical diagnostic equipment
About You
- Fast learner with excellent problem-solving skills
- Friendly and positive attitude
- Self-motivated and self-managing
- Ability to work in a highly technical, fast-paced, dynamic environment
- Ability to take ownership of a problem and see it through resolution
Special Requirements
To perform the duties of this position, the employee must be able to: hear and speak; see at changing focus distances; sit, stand, and walk; reach with arms; use hands to hold, feel, and manipulate objects; frequently lift and/move up to 50 pounds.
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 you’re applications is selected to proceed in our hiring process.
Unless otherwise stated, applications will only be considered from candidates eligible to work in Canada, or the county 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.
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