Medical Device Engineer

2 weeks ago

Cambridge, Ontario, Canada Smarter Alloys Full time

Smarter Alloys is a world leader in smart materials innovation, pioneering advanced shape memory materials for applications in medical devices, cleantech, automotive, and beyond. We are looking for a Medical Device Engineer to design and develop next-generation medical technologies powered by our proprietary shape memory alloy platform.

As a Medical Device Engineer, you will take ownership of the design, development, and testing of medical devices and components from concept through production. Working closely with R&D, quality, and manufacturing teams, you'll translate ideas into manufacturable products that meet performance, reliability, and regulatory requirements. This is a hands-on role for an engineer who thrives in a fast-paced, collaborative environment and wants to see their innovations make a real-world impact.

KEY RESPONSIBILITIES

  • Lead the end-to-end development of medical devices using advanced shape memory alloys
  • Support and contribute to the Quality Management System (ISO 13485)
  • Translate high-level concepts into manufacturable designs through rapid prototyping and iteration
  • Perform material characterization and mechanical testing under ISO/ASTM standards
  • Design and validate test setups for device and material performance
  • Collaborate cross-functionally with procurement, quality, production, and business development teams
  • Contribute to strategic development planning and continuous improvement initiatives
  • Guide or mentor junior team members when needed

REQUIRED QUALIFICATIONS

  • Bachelor's degree in Materials, Mechanical, or Biomedical Engineering
  • 3+ years of experience in medical device development within a regulated environment
  • Strong understanding of ISO 13485, FDA regulations, and QMS documentation
  • Demonstrated ability to manage projects independently from concept through production
  • Proficient in mechanical design principles, GD&T, and manufacturing processes
  • Hands-on experience with mechanical testing and data interpretation

PREFERRED QUALIFICATIONS

  • Experience with 3D CAD tools such as SolidWorks or AutoDesk
  • Background in shape memory alloys or advanced materials
  • Familiarity with laser processing and other precision manufacturing technologies
  • Demonstrated ability to make data-driven design decisions and optimizations

WORKING WITH SMARTER ALLOYS

Smarter Alloys is at the forefront of the smart materials revolution. With applications ranging from wearable technology to medical devices, our technology can be found across a wide range of industries, including medical/dental, automotive, energy harvesting, consumer electronics and sporting goods.

We are a small, innovative and fast-moving company that is on the cutting edge of the smart materials industry. We have aggressive growth goals and are looking for someone who is willing to put in the work to help us get there. If this sounds like you, we want to hear from you

We strive to build a team that reflects the diversity of the community we work in and encourage applications from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with disabilities.

Smarter Alloys | Cambridge, ON |

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