Mechanical Engineer – Medical Devices
Xpan
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.