Mechanical Engineer
4 weeks ago
Location: Toronto - Hybrid Position (On-site required with occasional remote work flexibility)
About Us:We're pioneering the future of medical technology. Our dedication to innovation, patient safety, and quality assurance has positioned us as a leader in medical device development. We are on a mission to transform healthcare through our cutting-edge medical devices, and we need exceptional talent to achieve our goals. Join us in making a meaningful impact on lives around the globe.
Position Summary:We are seeking a Mechanical Engineer with a passion for transforming high-level user and project requirements into groundbreaking medical devices. This role demands a blend of creativity, engineering excellence, and the ability to work collaboratively across departments to bring innovative products from concept to commercialization.
Key Responsibilities:- Translate user/project requirements into detailed engineering specifications, considering biomechanical end-use conditions.
- Design advanced 3D mechanical components, ensuring feasibility, manufacturability, and industrial design considerations.
- Lead prototype development, addressing assembly/testing issues through pilot and final builds.
- Develop automated software workflows for custom medical device orders, from digital health platforms to manufacturable designs.
- Ensure designs meet functional, biocompatibility, and sterilization requirements.
- Conduct structural assessments (FEA, modeling, physical testing) and compile Design History Files (DHF).
- Collaborate with cross-functional teams to align project priorities and drive success.
- Implement design improvements for manufacturing scalability and contribute to equipment specification and process development.
- Perform root cause analysis on product quality issues and contribute to supplier and part quality assessments.
- Support product safety certification and compliance with ISO 13485 and other relevant standards.
- Engage in patent submissions and maintain effective communication with all stakeholders.
Bachelor's or master’s degree in mechanical engineering or a related field.
Experience:
- At least 3+ years in the commercialization of medical devices with complex mechanical structures.
- Minimum of 5 years in CAD, assembly design, and lifecycle management.
Understanding: Strong understanding of DFM, industrial design, and various manufacturing techniques (3D printing, injection molding, extrusion, etc.).
Abilities: Demonstrated ability in DHF and DMR documentation, external supplier management, and critical thinking.
Others: Excellent project management skills and the ability to work within a quality management system. Nice to Have:
- Experience in custom medical device development
- Certification in process/quality engineering
- Knowledge of implant-grade biocompatible materials and reliability testing
- Experience in electromechanical medical system design and development
- Dynamic environment with ambitious goals.
- Hands-on work with mechanical test jigs and devices is required.
- Primarily on-site with occasional remote work flexibility.
You’ll be part of a team that’s transforming the future of healthcare. We offer a dynamic work environment, competitive salaries, comprehensive benefits, and opportunities for professional growth. If you’re ready to make a difference, apply today to join our mission in advancing medical technology.
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