Principal Mechanical Engineer - Medical Device, Wearables, 60601

Founded in 2014, we are an R&D Medical Device Manufacturing company developing AI and AR-based wearables utilizing brain computer interface technology for speech impaired individuals.

With offices in the US and Canada, we are seeking an experienced Principal Mechanical Engineer in Toronto to lead the design and development of innovative medical devices and wearable solutions. The ideal candidate will possess a strong background in mechanical design, product lifecycle management, and compliance with regulatory standards such as ISO 13485 and IEC 60601. This role will focus on creating user-friendly, safe, and effective medical products that enhance patient care.

Key Responsibilities

• Lead the mechanical design process for medical devices and wearables, ensuring compliance with regulatory standards.
• Conduct risk analysis and failure mode assessments to identify potential design issues and mitigate risks.
• Collaborate with cross-functional teams including industrial design, software, and manufacturing to develop comprehensive product solutions.
• Oversee the product lifecycle from concept development through mass production, ensuring design controls are maintained.
• Implement usability engineering principles to ensure human-centric design and improve user experience.
• Evaluate and select suitable materials, including biocompatible and medical-grade materials, for product development.
• Participate in verification and validation activities to ensure products meet performance and safety standards.
• Support the integration of soft goods and flexible materials into wearable devices, enhancing comfort and usability.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field; Master's degree preferred.
• Minimum of 8 years of experience in mechanical design, preferably in the medical device or wearable technology industry.
• Strong knowledge of regulatory standards including ISO 13485, IEC 60601, FDA, and MDR.
• Proficiency in product lifecycle management and concept development.
• Experience in risk analysis, verification and validation, and design controls.
• Familiarity with materials science and the selection of medical-grade and biocompatible materials.
• Demonstrated experience in design for manufacturability (DFM) and design for assembly (DFA).
• Excellent communication and teamwork skills, with the ability to lead cross-functional initiatives.

Benefits

• Competitive compensation, benefits, and career growth opportunities including relocation assistance to the Toronto area 
• Opportunity to work on life-changing technology that has a direct impact on patient outcomes
• Collaborative and supportive environment where innovation and creativity thrive
• The chance to shape the future of healthcare through pioneering wearable medical devices

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.