Xpan Inc. is a medical device company that designs and develops innovative surgical products aimed at reducing complications and improving workflow in minimally invasive surgeries. We are recruiting a well-rounded mechanical engineer to support the R&D and operations activities of the business. The candidate must have at least 3-5 years of work experience in the medical device field with Class II or III devices. The candidate must also be a quick learner who is interested in being in a dynamic, fast-paced startup environment. The candidate will work closely with the management, product development and manufacturing teams to design and commercialize a novel radially expanding trocar technology. The candidate must demonstrate excellence in product design and mechanical engineering, and have strong communication and collaboration skills.

The company is headquartered in Vaughan, Ontario and offers a flexible/hybrid work environment, and opportunities for rapid career growth.

Tasks & responsibilities:

• Support the development of new pipeline products.

• Design and iterate on new and existing product designs using 3D printing, and other rapid-prototyping techniques.

• Design parts for injection molding, using design for manufacturing principles.

• Develop and conduct benchtop & animal (pre-clinical) testing procedures and fixtures.

• Collect and analyze data using statistical methods, and author test reports.

• Draft design output documents such as engineering drawings and manufacturing work instructions.

• Create and maintain DHF documentation.

• Develop validation plans and conduct V&V testing (mechanical, biological, electrical).

• Support manufacturing and continuous improvement activities.

• Contribute to intellectual property development through generating new concepts and implementing them in practice.

• Conduct literature and/or intellectual property research and summarize results in succinct and organized methods.

• Communicate, negotiate, and manage relationships with contract manufacturers and suppliers.

• Support the quality team with maintenance of the QMS.

• Mentor and manage junior engineers and interns.

• Self-manage by setting high level objectives and granular tasks, especially under aggressive timelines.

• May assume multiple functional roles within the organization.

Candidate requirements

• Bachelor’s degree in mechanical engineering.

• 3-5 years of work experience in the medical device field, and Class-II/III medical devices according to FDA regulations.

• Familiarity and comfort with design requirements as per 21 CFR 820 and ISO 13485.

• Proficiency in CAD software, such as SolidWorks, is essential.

• Experience with CNC machining processes is preferred.

• Strong understanding of system design principles and mechanical knowledge is necessary.

• Excellent problem-solving skills, attention to detail, and ability to work collaboratively in a team environment are essential for success in this role.

Recent experience with:

• Design for injection molding.

• Process and design validation, and FMEA.

• Implementing scientific methods and iterative approaches in design and testing.

• Developing benchtop testing procedures and testing apparatus, performing tests, and analyzing data using statistical methods.

• Using hand, powered tools & comfortable with machine shop equipment.

• Design and modeling of parts and assemblies in SolidWorks and PDM.

• Developing parts through rapid prototyping methods, such as 3D printing.

• Developing benchtop testing procedures and testing apparatus.

Join us in driving innovation through mechanical engineering excellence!

Applicants are encouraged to submit an engineering portfolio to showcase their past experiences, as relevant to the position’s requirements.