Position Description:

Xpan Inc. is a medical device startup that develops surgical products aimed at reducing complications in minimally invasive surgery. We are recruiting a well-rounded mechanical engineer to support the R&D and operations activities of the business. The ideal candidate is a quick learner who is interested in being in a dynamic startup environment (jack-of-all-trades). The candidate will work closely with the management and the product development teams to commercialize a novel trocar technology. The position will be focused on mechanical engineering design of Class II medical devices. The company is headquartered in Vaughan, Ontario and offers a flexible/hybrid work environment.

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 engineering team with product complaints, and maintenance of the QMS.
• Mentor and manage junior engineers and interns.
• Self-manage (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 years of working 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 Creo and 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.

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