Job Description

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