Principal Mechanical Engineer

Our client is a fast-growing medical device company with offices in Toronto and California. They are looking for a Principal Mechanical Engineer with 10+ years of experience in mechanical design for medical devices and wearables.

This role demands a proven track record of leading projects across the full product lifecycle-from concept development to manufacturing. Prior experience with virtual reality (VR), augmented reality (AR), or related wearable technologies is highly desirable. As a key contributor to the team, you will ensure that designs meet clinical, regulatory, and user requirements, while pushing the boundaries of innovation.

Role and Responsibilities:

• Lead the design and development of mechanical systems for wearable medical devices, including enclosures, housings, and integrated soft goods.
• Drive projects through the entire product lifecycle, from initial concept and feasibility studies to design, prototyping, testing, and manufacturing ramp-up.
• Ensure compliance with medical device standards (e.g., ISO 13485, IEC 60601) and regulatory requirements (e.g., FDA, MDR).
• Prior experience delivering medical devices to the US market to be used in patient homes.
• Develop innovative solutions that seamlessly integrate mechanical, electronic, and soft-good components.
• Oversee risk analysis, failure mode assessments, and verification and validation activities.
• Collaborate with multidisciplinary teams, including industrial design, software, hardware, and regulatory teams, to deliver holistic, user-focused solutions.
• Engage with manufacturing partners to optimize designs for mass production, ensuring cost-effectiveness and scalability.
• Mentor junior engineers, fostering a culture of excellence, collaboration, and continuous learning.

Qualifications:

• Bachelor's degree in mechanical engineering, master's degree in mechanical engineering, biomedical engineering or optical engineering considered an asset.
• 10+ years of experience in mechanical design, with a focus on medical devices and wearable technology.
• Extensive experience leading projects across the full product lifecycle, including design for manufacturability (DFM) and design for assembly (DFA), including early stage ideation and concept design.
• Expertise in SolidWorks.
• Deep knowledge of materials science, including biocompatible and medical-grade materials.
• Excellent leadership and communication skills, with experience driving cross-functional collaboration.
• Experience with VR, AR, or related wearable technologies as part of a product portfolio.
• Proven ability to innovate at the intersection of hardware, software, and industrial design.