Manufacturing Engineer

Job Description

<h3>Job Description</h3><p>Job Description<p>Salary: <br /><p>General Accountability</p><p>This is a 2-year contract position. This role will support and drive improvements in the manufacturing of medical devices at Profound Medical. Minimize costs and sustain the product through its lifecycle.</p><p><br /></p><p>Continuously strive to increase the product reliability and quality of the products through working with engineering.</p><p>Transfer revision updates and new electromechanical designs of medical devices to manufacturing operations (in house and contract manufacturers).</p><p><br /></p><p>Duties and Responsibilities</p><ul><li>Oversee the manufacturing processes of assembling medical devices to ensure workflows are efficient; </li><li>Improve the manufacturing processes to ensure that technicians can be easily trained and able to build Profounds products;</li><li>Identify and track product quality through yields and complaints; propose and work with engineering on design or process improvements to improve product quality;</li><li>Design, document, and provision the manufacturing processes for ramping production;</li><li>Collaborate with design engineers to implement design for manufacturing. Participate in Design for <span >Manufacturing/Testability/Reliability</span> reviews;</li><li>Design/fabricate or select tooling, automation, and test equipment for the manufacturing processes;</li><li>Establish control and calibration procedures and protocols for tooling, automation, and test equipment to ensure that procedures and protocols are followed to deliver a quality product;</li><li>Establish process control points in the manufacturing process and establish testing requirements and procedures; develop and ensure maintenance of statistical controls;</li><li>Train and support production technicians on the day-to-day manufacturing to establish and maintain a smooth and efficient workflow;</li><li>Identify and collaborate with suppliers of outsourced parts, assemblies, and products. Support the resolution of obsolescence and pertinent quality issues;</li><li>Ensure that the manufacturing floor is adhering to all ISO, FDA, and quality requirements to ensure no major audit findings;</li><li>Participate in Corrective Action and Preventative Action Teams, lead product failure investigations both internally and externally, and design and perform design of experiments techniques to establish root cause failure modes;</li><li>Assist in validation and verification of production processes and manage validation resources, prepare and present validation and verification reports to meet ISO 13485 requirements;</li><li>Adhere to and support all ISO 13485 guidelines, support audits, and ensure product compliance to all applicable agency codes;</li><li><span >Recommend/evaluate/implement</span> opportunities for continuous process and product improvement and lead Lean Manufacturing initiatives to improve production rates, reduce costing, and improve quality of output;</li><li>Support EHS activities and initiatives to comply with safety regulations;</li><li>Support any other initiatives or projects as requested</li></ul><p><br /></p><p>Education</p><ul><li>Bachelors degree in Engineering.</li></ul><p><br /></p><p>Key Attributes </p><p>(experience, skills and technical knowledge)</p><ul><li>Up to 2 years relevant experience is preferred;</li><li>Experience with design and testing of electromechanical systems preferred;</li><li>Previous experience in a Medical Device Manufacturing environment is an asset;</li><li>Exposure to ISO 9001 quality system minimum. Preferred, exposure to ISO 13485 standard; </li><li>Employs a results-oriented work style and teamwork-oriented approach to meeting objectives;</li><li>Demonstrates the ability to prioritize duties, multi-task, and quickly assume new tasks to function productively in a fast-paced environment;</li><li>Proven ability to establish working relationships with design engineers, operators, and QA personnel;</li><li>Strong communication skills, written and oral;</li><li>Possess excellent attention to detail to ensure accuracy;</li><li>Able to travel infrequently, as required;</li><li>Ability to interpret technical drawings, dimensions, tolerances, etc;</li><li>Ability to interpret circuit schematics;</li><li>Proven ability to design manufacturing tests of subassemblies, electrical and mechanical;</li><li>Knowledge of test software such as LabView.</li></ul><p><br /></p><p>We thank you for your interest in Profound Medical. Please note only candidates who are short-listed will be contacted.</p><p><br /></p><p><em>We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.</em></p></p></p>