Job Description

Biomedical Engineer - Mechanical Design
To support our ambitious R&D team in developing next-generation medical devices, we are seeking an experienced and motivated Biomedical Engineer with a strong background in mechanical design. Reporting to the R&D leadership, you will play a key role in designing and building innovative medical device products that directly improve patient outcomes and quality of life for people with respiratory conditions.
Roles and Responsibilities
As a member of our Agile development team, you will support THORASYS' product development activities, coordinate cross-functional efforts, and enhance product quality and reliability.
Specific responsibilities include:

• Participate CAD design and optimization of new or existing medical device products with emphasis on user needs, regulatory compliance, function, reliability, performance, safety, and quality.
• Support mechanical development activities including prototyping, testing, and hands-on experimentation to validate design concepts and performance.
• Conduct verification, qualification, and validation studies on existing and new products.
• Prepare and maintain comprehensive technical documentation in compliance with medical device regulatory requirements.
• Support risk management activities (DFMEA and PFMEA) and conduct risk management reviews on existing products.
• Support the transfer of designs to production, including design for manufacturability, test equipment development, fixtures, inspection protocols, and work instructions.
• Drive continuous product and process improvements to enhance performance, reliability, and user experience.
• Coordinate Design Change and Process Change activities across departments.
• Support customer complaint investigations, including product/record review, health risk assessments, identification of CAPAs, and report generation.
• Assist with regulatory approvals and respond to regulatory questions for existing products.
• Lead commercialized product change project teams from concept through implementation.
• Maintain compliant and thorough design history files.
• Prioritize and uphold high standards of security and data privacy in accordance with THORASYS procedures and policies.

Competencies and Qualifications
Education:

• Bachelor's degree in Biomedical Engineering (specialization in mechanical design), Mechanical Engineering, or a related engineering discipline with proven mechanical design capabilities.

Required Competencies:

• Strong understanding of design methods, manufacturing processes, and medical device-specific requirements.
• Experience with regulatory environments such as ISO 13485, IEC 62304, IEC 60601, FCC, and UL, with a focus on design control for medical devices (highly desirable).
• Demonstrated applied knowledge of Advanced Quality tools including Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
• Ability to read, interpret, and create detailed CAD drawings.
• Proven ability to work cross-functionally with Operations, Product Development, QA, Regulatory, and Marketing teams.
• Experience with NC/CAPA processes.
• Proficiency with design-related software (SolidWorks, advanced simulation software, etc.).
• Computer proficiency with Minitab or similar statistical analysis programs.
• Highly organized with excellent problem-solving skills, creativity, and the ability to work under pressure.
• Excellent technical writing, communication, and teamwork skills.
• Excellent communication skills; fluency in English and French (oral and written) required.
• Knowledge of project management tools and methodologies.
• Understanding of Agile development practices, particularly the Scrum framework.
• Experience with Jira is an asset.

Experience:

• 2-3 years of experience as a Design Engineer in a regulated medical device environment preferred.

Legal Requirements:

• Legally authorized to work in Canada.

Benefits
THORASYS offers competitive compensation packages, including supplemental insurance coverage, retirement savings programs, and policies designed to support personal and professional growth while promoting a healthy work-life balance.
Job Type: Full-time, Permanent

Skills Required