Staff Manufacturing Engineer
Baylis Medical is a leading developer, manufacturer and supplier of high-technology medical devices for cardiology, radiology and spine products. Baylis Medical products are marketed in over 65 countries. Our goal is to conceive, develop, manufacture, and sell state-of-the-art medical products that will improve the lives of people around the world. To assist us in realizing our goal, Baylis Medical adheres to four main guiding principles: Technological Leadership, Employee Development, Customer Service and Corporate Social Responsibility.
We are growing and currently seeking a Staff Process Engineer to join our Engineering team. The Staff Process Engineer is responsible for the design, development, validation, verification and implementation of new and revised manufacturing lines or integrated system of manufacturing processes. They are a key member of the product realization teams to ensure product manufacturability and successful transfer to production. They plan for all project activities, participate in the project scope and target definition as related to the manufacturing. They are expected to prepare documentation in accordance with the Baylis Quality Management System, additionally developing novel manufacturing methods and new best practices.
Snapshot of Responsibilities
- Adhere to all requirements of the Quality Management System
- Demonstrate Baylis values, works with integrity and a supportive corporate member
- Member of a product development team as lead manufacturing line designer
- Responsible for or author design input and output documentation for a manufacturing line.
- Conduct and maintain process risk assessment activities (including PFMEA's) in order to identify critical process parameters and develop appropriate control plans to mitigate risks.
- Develop Validation Plans, protocols and process controls
- Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions
What you bring to the team
- Post-secondary degree in Engineering required; preference for Mechanical, Advanced Manufacturing & Automation Technology degrees
- Minimum 5-7 year related working experience in process design/development and product design for manufacturability in the medical device industry, specifically catheter manufacturing required or experience working in a highly regulated industry
- Experience with extrusion of medical devices
- Experience with sterile packaging of medical devices
- Experience with laser welding and laser cutting
- Experience with adhesive technologies (Epoxy, UV)
- Production fixture design and inspection fixture design
- Good working knowledge of medical device manufacturing requirements and FDA/ISO compliance guidelines
- Experience in process validation, process FMEA and project management
- Experience in Lean manufacturing principles
- Excellent analytical and communication skills (both written and oral)
- Organization and time management skills
What we have to offer
- Opportunity for growth
- Competitive salary and benefits
- RRSP matching
- Flexible start times
- On site gym facility
Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process.
While we thank all applicants, only those being considered for an interview will be contacted.
Meet Some of Baylis Medical's Employees
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Linus and his team develop new medical devices, overseeing and reviewing the technical challenges involved while also communicating with other departments in order to get products to market.
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