General Accountability

The Senior Mechanical Developer leads the end-to-end mechanical design and development of the TULSA-PRO system and future product platforms. This role provides technical leadership, drives system-level design strategy, and ensures alignment with regulatory, manufacturing, and business objectives from concept through product release.

Duties and Responsibilities

• Drive the design and continuous improvement of mechanical aspects of the product.
• Lead the architecture, design strategy, and system-level integration of mechanical subsystems.
• Translate user, clinical, and business needs into robust system requirements and engineering specifications.
• Lead design reviews, risk assessments, and cross-functional technical decision-making.
• Produce and review DHF and DMR documentation to support transfer to test and manufacturing.
• Partner with customers, clinical users, marketing, sales, and operations to identify product needs and opportunities for improvement.
• Lead investigations of product complaints at clinical and customer sites, perform root cause analysis, and drive timely remediation.
• Contribute to risk management deliverables including hazard analysis and design risk mitigations.
• Drive design for manufacturability, reliability, serviceability, and cost optimization initiatives.
• Contribute to a positive, high-performance work culture.
• Perform all duties in compliance with the quality management system and actively contribute to continuous improvement of the QMS.

Education

Bachelor’s degree in mechanical engineering or a related discipline

Key Attributes

Required:

• 8+ years of industrial experience
• Demonstrated experience leading complex product development efforts from concept through manufacturing transfer.
• Extensive knowledge of SolidWorks and mechanical system design best practices.
• Excellent verbal and written communication skills, with the ability to communicate clearly, concisely, and effectively across functions.
• Strong mechanical aptitude, including the ability to use common shop tools and measurement equipment.
• Tenacious problem solver who is highly organized, detail oriented, and accountable.
• Working knowledge of medical device standards and regulations such as IEC 60601-1 and ISO 10993.
• Deep knowledge of manufacturing processes including machining, injection molding, urethane casting, 3D printing, and sheet metal fabrication.
• Demonstrated ability to translate user needs into design requirements and technical specifications.
• Demonstrated ability to troubleshoot complex technical issues, perform root cause analysis, and implement effective corrective actions.
• Knowledge of ASTM standards and test methods.
• Strong competency in mechanical engineering fundamentals including kinematics, solid and fluid dynamics, heat transfer, and material strength.

Desired:

• Industrial design experience; a design portfolio is an asset.
• Experience with biocompatibility, and designing for cleaning & disinfection
• Experience working with MRI-compatible devices.
• Knowledge of electromechanical system design and integration.
• Familiarity with mechatronic component sizing and sourcing.
• Experience working with adhesives, sterilization methods, and disinfection methods.
• Experience with statistical analysis and data-driven design decisions.
• Prior experience mentoring engineers or serving as a technical lead.

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

The expected base salary range for this role is $120,000 - $150,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.

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.