Job Description

The Company

Sonele develops and manufactures medical devices within an ISO13485 & FDA-registered facility and is also a leading ultrasound OEM manufacturer specializing in high-performance transducers. Our expertise and experience include all stages of product-to-market and provides a unique ability in getting necessary technologies into consumer hands. Sonele's ultrasound division designs and manufactures medical and industrial transducers offering significant advantages in performance and reliability. We are located near Highway 407 and Woodbine Ave in Markham, ON.

The Opportunity

We are looking for a full-time candidate to fill the Manufacturing Engineer position who will support the manufacturing team in developing manufacturing processes and procedures, design transfer activities, process validation and change control, and various product development / production activities.


The selected candidate will also be provided with health benefits with premiums fully paid by the company after probation period. Free parking is available on site.

Responsibilities

Analyze manufacturability, costing and lead times of electro-mechanical systems. Work together with the Engineering team, cross functional teams (Service, Manufacturing, Production) as well as suppliers to meet customer deliverables. Develop assembly and testing procedures to facilitate product manufacturing. Lead selection, installation, qualification (IQ/OQ/PQ), validation of test methods, and continuous support for the tools and equipment utilized in manufacturing. Generate production schedules. Collaborate with the Supply Chain team in identifying and qualifying new suppliers. Support the manufacturability of new products through research, feasibility testing, and process validation. Assist in engineering prototype builds within the product development process. Plan, execute, and document verification/validation/engineering testing. Provide training, guidance, and supervision for Production Technicians, covering assembly, testing, and troubleshooting of electromechanical equipment. Implement lean manufacturing principles and employ creative problem-solving techniques. Create and implement Nonconformance reports and Engineering Change Requests. Cultivate a culture of innovation and creativity within the commercialization team. Deliver progress reports on a regular basis.

Qualifications

Bachelor's Degree (or equivalent) in a relevant Engineering discipline, with a preference for Mechanical/Mechatronics. 5 or more years of expertise in Medical Devices Manufacturing, Testing, or Process Engineering. Experience in Medical Device Manufacturing is required. Strong experience with 3D CAD software, preferably in SolidWorks. Ability to read and follow mechanical and electrical drawings, schematics, and bills of materials, including good knowledge of GD&T. Ability to troubleshoot and adapt to on-going changes to suit the needs of the team and/or customers. Knowledge of different manufacturing processes: CNC Machining, Sheet metal Fabrication, Injection Molding, etc. Strong planning and relationship-building skills. Showcase innovative problem-solving skills and proven adaptability. Experience and a profound understanding of the full development life cycle. Experience in a regulated environment (ISO 13485, FDA, etc.) and adherence to a Quality Management System. Expertise in lean manufacturing principles. Proficient with Microsoft Office Suite, especially in Outlook, Word, and Excel. Fluent communication skills in English.

Disclaimer

The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.