Tornado Medical Systems is an early-stage medical imaging and spectroscopy company. We develop innovative and proprietary devices that provide clinicians and scientists with improved tools to detect and diagnose disease. We combine rigorous design and engineering with world-class scientific and medical expertise to deliver distinctive value to our commercial partners.
The successful candidate will work under the supervision of our Magnetic Resonance (MR) Systems Engineering in the design and development of mechanical components for a medical device intended for use in a hospital environment. The Mechanical Engineer will participate in all stages of medical device development from evaluation and recommendation of specific concepts,development of appropriate designs through to management of external vendors in the manufacturing of sub-components.
Responsibilities:
- Capture detailed engineering requirements.
- Work closely with electrical and software engineers to develop designs with a system-wide perspective using 3D CAD tools.
- Source and verify components to ensure that they meet design specifications.
- Integrate and package MRI system assemblies and sub-systems.
- Design, setup, and perform experiments as well as specify unit level testing plans and protocols.
- Support Risk Management process including Hazard Analysis, Design FMEA, Use FMEA.
- Coordinate mechanical engineering through development to manufacturing and sustaining engineering activities.
- Complete projects consistent with company objectives by engaging other engineering, research, regulatory, quality and business development staff.
- Prepare and maintains accurate documentation of concepts, designs, drawings and manufacturing processes consistent with the company’s quality management system.
The position will be located in Oshkosh, Wisconsin or Toronto, Ontario with travel to customer sites as needed.
Required Education/Experience:
- Minimum bachelor’s degree in mechanical engineering.
- Master’s degree is beneficial
- P.Eng beneficial
- 3 to 5 years of relevant experience.
- Familiarity with 3D design and simulation tools– SolidWorks preferred
- Demonstrated ability to design mechanical sub-systems integrating with non-mechanical sub-systems (such as electrical and optical components).
- Machine design / understanding of core mechanical engineering principles
- Experience with Non-Ferrous Metals and Plastics for use in an MR environment
- Direct experience with FDA regulated medical devices and working in an ISO quality environment
Additional experience sought (not essential):
- Exposure to working under design controls in a regulated industry (e.g. aerospace, military or medical device sector)
- Familiarity with designing for manufacturability
- Familiarity with 60601 family of standards and designing to meet safety requirements stipulated by these standards
- Familiarity with 21CFR and ISO standards applicable to medical devices, including CE Mark.
- Experience rapid prototype design and build of plastic and formed metal parts for proof of concept and usability testing.
Other requirements:
- Ability to travel to vendors and customer sites at least once a month.
- Proficient in both oral and written communication
- Proficient in computer applications – MS Office Suite
- Self-motivated
- Effective communicator
