Process Engineer, Transducer Manufacturing, Markham, Canada (FUJIFILM VisualSonics, Inc.)
FUJIFILM VisualSonics, Inc. VisualSonics is a rapidly growing biomedical company and the world leader in developing high-resolution ultrasound devices for small animal research. VisualSonics offers a pleasant and progressive work environment with a competitive benefits package. We support a strong and dedicated team of individuals who are focused on continually innovating our product offering, servicing our customers, and supporting each other's efforts to sustain our competitive advantage. We are based in Toronto, Canada.
Under the direction of the Vice President, Engineering, the Process Engineer, Transducer Manufacturing shall be responsible for all aspects of the control of the production of transducers including fabrication, qualification and quality of all transducers manufactured at VisualSonics. This position has dotted line reporting to the Sr. Manager, Manufacturing and shall work closely with the QA and Design groups to ensure manufacturability and reliability of new designs.
- Recruit, train, and develop talent within the Transducer Manufacturing group
- Ensure transducer manufacturing capacity is sized to the forecasted demand.
- Audit manufacturing processes to ensure conformity to documented requirements.
- Design the value stream and ensure production flows – building, assembly and testing of products; meet timelines and customer delivery requests
Clinical Process Control
- Document by specification, procedure and/or assembly instructions or otherwise to capture all process requirements and instructions of the manufacturing process.
- Ensure equipment, tooling and fixtures for manufacturing processes are developed, documented and qualified for its intended use.
- Ensure manufacturing equipment, tooling, and fixtures are maintained by preventative maintenance, inspection and calibration.
- Specify and implement process controls to maintain process chemicals and gasses.
- Ensure the device history records are complete and accurate while non-conforming items are dispositioned appropriately.
- Establish traceability requirements for individual products/processes.
- Develop and maintain the Bill of Material (BOM) structure and the device master records that control the configuration of all end item products.
- Ensure all manufacturing processes are controlled and validated.
- Corrective Action and Process Improvement
- Identify, diagnose, and resolve manufacturing issues related to the use and/or support of VisualSonics products.
- Document and communicate manufacturing solutions and recommendations.
- Help transfer designs from Engineering into Manufacturing.
- Seek continuous improvement in manufacturing of all VisualSonics products through the use of quality system tools (NPR’s, CAR’s, etc.)
- Other duties as assigned by Department Head
Knowledge and Experience:
- Knowledge of laser processing and micromachining.
- Knowledge of medical device process validation and traceability requirements
- Knowledge of manufacturing test development and validation
- Thorough knowledge of software quality and regulatory standards such as ISO 9001, ISO 13485 and FDA QSR.
- Familiarity with manufacturing techniques for prototypes and production versions of products.
- Minimum five years experience in the manufacturing of (preferably medical) devices requiring a high degree of traceability and documentation.
- Familiarity with machine shop tools and procedures, including numerically controlled tools.
- Experience with all aspects of product development process.
- Thorough understanding of product development methodology, including specification, design, prototyping, system integration and validation.
- Ability to assist in project planning and scheduling.
- Familiarity with ultrasound imaging concepts.
- Ability to work independently as well as within a team of professionals.
- Ability to plan and execute manufacturing tasks within set deadlines.
- Ability to effectively manage and prioritize assigned tasks.
- Ability to apply innovative thinking to solving problems.
- Ability to leverage relationships across other business units and with external sources.
- Accuracy and strong attention to detail is essential.
- Good aptitude for troubleshooting.
FUJIFILM VisualSonics, Inc. Visit us today to learn more about our exciting technologies and how you can make a difference. To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at www.visualsonics.com.
FUJIFILM VisualSonics, Inc. is an Equal Opportunity Employer.