Manufacturing Process Engineer, Intermediate
Synaptive Medical Inc.
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 Manufacturing Process Engineer will be responsible for establishing, qualifying, and improving manufacturing processes for the assembly, troubleshooting, and testing of sophisticated, sensitive, precision medical instruments for neurosurgical and imaging applications.
What you’ll do
- Evaluate, establish, improve, and qualify manufacturing processes following GMP and Synaptive Medical’s guidelines by understanding product requirements and applying knowledge of product design, fabrication, assembly, tooling, and materials.
- Develop, implement, and transfer of manufacturing processes and procedures for new product introductions and continuous manufacturing improvement opportunities.
- Interaction with various departments - Production, Engineering, Quality, Service, and others- to facilitate communication, introducing changes, root causes troubleshooting, Field feedback.
- Support or lead outsourcing activities including technology transfer, manufacturers qualifications, training, documentation completion.
- Support the Production Team by leading technical troubleshooting efforts related to electromechanical systems, computer systems, and imaging systems.
- Develop, build, and qualify manufacturing testing stations including hardware and software installations, assembly test fixtures/jigs, and other tests equipment as required.
- Conduct training and provide guidance and supervision for Production Technicians on assembling, testing, troubleshooting, and repair techniques of electromechanical equipment.
- Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout while meeting manufacturing process, product, and quality assurance requirements.
- Provide inputs to the product development staff for continuous improvement initiatives for product manufacturability and serviceability.
- Develop and update manufacturing work instructions, device master records, and other documentation as required and implement approved changes through ECO process.
- Assure product and process quality by designing testing methods and establishing standards to confirm manufacturing process capabilities.
- Provide manufacturing decision-making information and communicate production status, deviations, issues, and general information to manufacturing management.
- Assist during internal/external audit process.
What you’ll need
- Minimum of bachelor’s degree (or equivalent) in a relevant Engineering discipline or equivalent education gained through work experiences.
- Minimum 3 years’ experience with manufacturing techniques involved with electromechanical systems (medical device preferred).
- Knowledge of GMP and experience working in an ISO 13485 environment strongly preferred.
- Experience & knowledge in Electromechanical Engineering, FMEA, Lean Manufacturing, DFM, DFA principles and applications.
- Magnetic Resonance Imaging manufacturing experience or equivalent is a plus.
- Excellent problem-solving skills, technical proficiency, and analytical abilities.
- Excellent communication skills (direct, Teams/Zoom, email, reports) and knowledge in technical writing.
- Able to adapt and drive change in a product development & manufacturing setting.
- Ability to identify potential problems and take appropriate action.
- Good organizational skills and ability to coordinate workload to ensure that deadlines and targets are met.
- Good computer skills (MS Office applications).
- Must be able to work with others in different disciplines.
- Must be able to work in a team setting and on individual basis, as required.
- Ability to travel (~10-20%)
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.
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.
- Job Family Manufacturing
- Pay Type Salary
Something looks off?