General Accountability

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.

Continuously strive to increase the product reliability and quality of the products thru working with engineering.

Transfer revision updates and new electromechanical designs of medical devices to manufacturing operations (in house and contract manufacturers).

Duties and Responsibilities

• Oversee the manufacturing processes of assembling medical devices to ensure workflows are efficient;

• Improve the manufacturing processes to ensure that technicians can be easily trained and able to build Profound’s products;

• Identify and track product quality through yields and complaints; propose and work with engineering on design or process improvements to improve product quality;

• Design, document, and provision the manufacturing processes for ramping production;

• Collaborate with design engineers to implement “design for manufacturing”. Participate in Design for Manufacturing/Testability/Reliability reviews;

• Design/fabricate or select tooling, automation, and test equipment for the manufacturing processes;

• 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;

• Establish process control points in the manufacturing process and establish testing requirements and procedures; develop and ensure maintenance of statistical controls;

• Train and support production technicians on the day-to-day manufacturing to establish and maintain a smooth and efficient workflow;

• Identify and collaborate with suppliers of outsourced parts, assemblies, and products. Support the resolution of obsolescence and pertinent quality issues;

• Ensure that the manufacturing floor is adhering to all ISO, FDA, and quality requirements to ensure no major audit findings;

• 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;

• Assist in validation and verification of production processes and manage validation resources, prepare and present validation and verification reports to meet ISO 13485 requirements;

• Adhere to and support all ISO 13485 guidelines, support audits, and ensure product compliance to all applicable agency codes;

• Recommend/evaluate/implement opportunities for continuous process and product improvement and lead “Lean Manufacturing” initiatives to improve production rates, reduce costing, and improve quality of output;

• Support EHS activities and initiatives to comply with safety regulations;

• Support any other initiatives or projects as requested

Education

• Bachelor’s degree in Engineering.

Key Attributes

(experience, skills and technical knowledge)

• Minimum 2 years relevant work experience; experience with design and testing of electromechanical systems preferred;

• Previous experience in a Medical Device Manufacturing environment is an asset;

• Exposure to ISO 9001 quality system minimum. Preferred, exposure to ISO 13485 standard;

• Employs a results-oriented work style and teamwork-oriented approach to meeting objectives;

• Demonstrates the ability to prioritize duties, multi-task, and quickly assume new tasks to function productively in a fast-paced environment;

• Proven ability to establish working relationships with design engineers, operators, and QA personnel;

• Strong communication skills, written and oral;

• Possess excellent attention to detail to ensure accuracy;

• Able to travel infrequently, as required;

• Ability to interpret technical drawings, dimensions, tolerances, etc;

• Ability to interpret circuit schematics;

• Proven ability to design manufacturing tests of subassemblies, electrical and mechanical;

• Knowledge of test software such as LabView.

We thank you for your interest in Profound Medical. Please note only candidates who are short-listed will be contacted.

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.