(Khn-254) Manufacturing Process Specialist

Detalles de la oferta

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 includes 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 What You'll Do Develop, implement, and transfer manufacturing processes and procedures for new product introductions and continuous manufacturing improvement opportunities.Interact with various departments - Production, Engineering, Quality, Service, and others - to facilitate communication, introduce changes, troubleshoot root causes, and gather field feedback.Support or lead outsourcing activities including technology transfer, manufacturers qualifications, training, and 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 test 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 the 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 processes.What You'll Need Minimum of a bachelor's degree (or equivalent) in a relevant Engineering discipline or equivalent education gained through work experiences.Minimum 5 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.It'd Be Amazing If You Had Magnetic Resonance Imaging manufacturing experience or equivalent is a plus.About You Excellent problem-solving skills, technical proficiency, and analytical abilities.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.Must be able to work with others in different disciplines.Must be able to work in a team setting and on an individual basis, as required.COVID-19 Considerations 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 of 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 in respectfully considering each other's thoughts and opinions and by working towards a greater common goal, saving lives.
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