Mechanical Engineer: Medical Device Design and Manufacturing

Mechanical Engineer: Medical Device Design and Manufacturing Company: Corvita Biomedical Inc. Location: Greater Toronto Area, Ontario, Canada Employment: Full-time, permanent Experience: 1 to 3 years of relevant product-development experience Reports to: Head of Engineering Start date: Mid-October About Corvita Biomedical Corvita Biomedical Inc. is a mission-driven medical device startup transforming neonatal healthcare globally. We are developing the ARK Incubator system designed to democratize access to intensive care for newborns. Our technology addresses the global crisis where millions of infants die annually due to lack of access to proper neonatal intensive care. As a member of our team, you'll have the unique opportunity to directly impact infant mortality rates and health outcomes on a global scale. Role Summary We are looking for a hands-on Mechanical Engineer to own the day-to-day mechanical development of the ARK platform, from subsystem requirements and engineering prototypes through design verification and pilot manufacturing. You will develop the enclosure, structural assemblies, airflow and thermal-management hardware, access features, mounting systems, and mechanical interfaces that bring ARK's subsystems together. This is an individual-contributor role with substantial technical ownership and close support from the wider engineering, quality, regulatory, and manufacturing team. Key Responsibilities Mechanical architecture and detailed design Translate approved user needs, system requirements, identified risks, and manufacturing constraints into clear mechanical requirements and acceptance criteria.Define mechanical interfaces among the incubator chamber, thermal-control components, sensors, electronics, displays, access features, cable paths, and approved third-party subsystems.Develop and maintain 3D CAD models, assemblies, production drawings, mechanical bills of materials, and interface-control information.Apply GD&T, tolerance-stack analysis, suitable fits and finishes, and disciplined configuration and change control.Design for thermal performance, airflow, cleanability, disinfection compatibility, ergonomics, durability, transport, service access, and assembly. Engineering analysis prototyping and verification Build or coordinate prototypes, engineering test articles, fixtures, and design-representative assemblies.Develop verification methods, protocols, acceptance criteria, and reports for mechanical and environmental requirements.Conduct and document dimensional, structural, thermal, airflow, access, durability, transport, and usability-related testing.Investigate failures, determine root cause, implement controlled design changes, and confirm that corrective actions are effective. Medical-device design controls and risk Maintain traceability from mechanical requirements through design outputs, risk controls, reviews, and verification evidence.Contribute to hazard analysis, design FMEA, use-related risk reviews, design reviews, nonconformity investigations, and engineering change assessments.Create accurate, reviewable records for the design and development file and support technical documentation for regulatory submissions. Manufacturing and supplier readiness Apply design-for-manufacturing and design-for-assembly principles throughout development.Work with suppliers and contract manufacturers on process selection, quotations, tooling, tolerances, inspection methods, and component qualification.Develop assembly instructions, inspection criteria, service information, and specifications for jigs and fixtures. Required Qualifications Bachelor's degree in Mechanical Engineering, Mechatronics Engineering, Biomedical Engineering with a strong mechanical focus.Typically 1 to 3 years of experience developing physical or electromechanical products.Proficiency with a professional 3D CAD platform such as SolidWorks, Creo, & Altium.Practical experience creating production drawings, applying GD&T, and performing tolerance analysis.Working knowledge of machining, sheet metal, molded plastics, additive manufacturing, and mechanical assembly.Hands-on ability to prototype, assemble, instrument, test, troubleshoot, and improve mechanical systems.Ability to write clear requirements, test procedures, technical reports, and manufacturing documentation. Preferred Qualifications Experience in medical devices, laboratory equipment, aerospace or automotive.Familiarity with medical-device design controls, ISO 14971 risk-management concepts, requirements traceability, and controlled change.Experience performing or coordinating FEA, CFD, vibration, drop, transport, or thermal analysis.Familiarity with medical-grade polymers, cleanability and disinfection requirements, and biological-evaluation considerations.Experience with PDM or PLM systems, contract manufacturers, tooling vendors, and first-article inspections.Awareness of IEC 60601, IEC 60601-2-19, IEC 62366-1, and ISO 10993 concepts as applicable to product design.P.Eng. designation or eligibility for future registration is an asset but is not required. What We Offer Meaningful ownership of defined work in an early-stage medical-device program.Hands-on exposure to requirements, prototyping, integration, verification, and manufacturing preparation.Close collaboration with engineering, clinical, quality, regulatory, and manufacturing contributors.Hybrid work with regular access to Corvita's Greater Toronto Area development environment.The opportunity to help establish practical engineering processes as the team grows. How to Apply Please email the following to hello@corvitabiomedical.com: Resume or CV.A brief cover letter explaining your interest and relevant experience.An optional portfolio or short description of two or three relevant mechanical-design projects.Please do not include confidential or proprietary information from a current or former employer. Applications will be reviewed on a rolling basis until the position is filled.