Director of Hardware Engineering

Myant Shared Service Corp.•Mississauga, ON

About The Position

Myant is redefining healthcare through Textile Computing™, integrating advanced materials, biosensors, electronics, data, and intelligent software into everyday garments that enable continuous health monitoring and personalized care. As we scale SKIIN and expand the capabilities of Myant Health, we are seeking a Director of Hardware Engineering to lead the development and commercialization of our wearable hardware platforms. This role is responsible for providing technical and organizational leadership across Myant’s hardware engineering organization, including Electrical Engineering, Mechanical Engineering, Systems Engineering, Embedded Hardware, Product Development Engineering, and Hardware Integration. The Director of Hardware Engineering will ensure our wearable products are designed for performance, manufacturability, reliability, regulatory compliance, and commercialization. Success in this role requires a systems-thinking leader who understands how hardware integrates with firmware, software, mobile applications, cloud infrastructure, advanced textiles, manufacturing, clinical requirements, and regulatory standards. While this position does not directly manage software engineering, it plays a critical role in ensuring seamless integration across the entire product ecosystem through close cross-functional collaboration. This is both a strategic and hands-on leadership position. You will define the hardware engineering roadmap, build and mentor high-performing engineering teams, establish scalable engineering processes, and drive execution from concept through commercialization. You will help shape the future of Myant’s wearable health technologies while ensuring engineering excellence throughout the product lifecycle.

Requirements

Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Systems Engineering, or a related discipline.
10+ years of progressive engineering leadership experience developing complex hardware products within medical devices, wearable technologies, connected devices, consumer electronics, or related industries.
Strong preference for candidates with Electrical Engineering or Biomedical Engineering backgrounds.
Demonstrated experience leading multidisciplinary hardware engineering organizations.
Proven success bringing regulated hardware products from concept through commercialization.
Deep understanding of embedded electronics, PCB development, sensor integration, power systems, wireless connectivity, and hardware architecture.
Strong knowledge of manufacturing processes, supplier management, design transfer, and production scaling.
Experience operating within ISO 13485, FDA 21 CFR Part 820, ISO 14971, and related quality management systems.
Strong systems engineering mindset with the ability to understand technical dependencies across hardware, firmware, software, manufacturing, and product development.
Excellent leadership, communication, stakeholder management, and organizational development skills.
Proven ability to operate effectively within fast-paced, high-growth product organizations.

Nice To Haves

Wearable medical devices, biosensors, digital health platforms, or connected healthcare technologies.
Flexible electronics, smart textiles, or advanced materials.
Experience integrating hardware with embedded firmware, cloud platforms, mobile applications, and data systems.
Direct experience supporting FDA 510(k), De Novo, Health Canada MDL, or CE Mark submissions.
Experience scaling engineering organizations through periods of rapid growth.
Experience working closely with contract manufacturers and global supply chains.
Familiarity with reliability engineering, environmental testing, EMC/EMI compliance, and product certification.
Passion for building innovative healthcare technologies that improve patient outcomes.

Responsibilities

Lead and mentor multidisciplinary hardware engineering teams, including Electrical Engineering, Mechanical Engineering, Systems Engineering, Embedded Hardware, Product Development Engineering, and Hardware Integration.
Establish a unified hardware engineering strategy aligned with product roadmaps, business objectives, regulatory requirements, and commercialization goals.
Build a high-performing engineering organization focused on technical excellence, innovation, accountability, collaboration, and execution.
Develop engineering processes, performance metrics, and organizational structures that enable predictable product development and scalable growth.
Foster a culture of continuous improvement, technical rigor, mentorship, and engineering ownership.
Own the hardware architecture for Myant’s wearable health platforms, including sensors, electronics, embedded hardware, power systems, connectivity, and textile integration.
Translate product, clinical, manufacturing, and regulatory requirements into executable engineering plans and technical roadmaps.
Lead hardware development from concept through prototype, verification, validation, manufacturing transfer, and commercialization.
Drive architecture decisions that optimize performance, reliability, manufacturability, scalability, power consumption, and product cost.
Identify technical risks early and develop mitigation strategies throughout the development lifecycle.
Lead systems engineering activities that ensure seamless integration between wearable hardware, embedded firmware, software platforms, mobile applications, cloud infrastructure, manufacturing processes, and advanced textile technologies.
Partner closely with Software Engineering, Product Management, Clinical, Regulatory, Manufacturing, Data Science, and Quality teams to ensure hardware solutions support the overall product vision.
Champion systems-level thinking throughout product development, balancing innovation with practical execution and commercial readiness.
Drive engineering traceability, ensuring hardware design outputs map directly to product requirements, verification activities, and risk management documentation.
Resolve cross-functional technical integration challenges throughout development.
Ensure hardware products are designed and developed in accordance with ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 60601 (where applicable), and other relevant regulatory standards.
Establish rigorous engineering design reviews, verification, validation, reliability testing, and documentation practices.
Ensure Design History Files (DHF), Device Master Records (DMR), engineering change documentation, and technical files remain audit-ready throughout development.
Support engineering activities required for FDA, Health Canada, CE Mark, and other regulatory submissions.
Partner with Manufacturing, Supply Chain, Operations, and Quality teams to ensure products are designed for manufacturability, assembly, testability, scalability, and cost-effective production.
Lead engineering support during EVT, DVT, PVT, pilot production, and manufacturing scale-up.
Drive Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Test (DFT), Design for Reliability (DFR), and Design for Serviceability initiatives.
Collaborate with suppliers and manufacturing partners on component selection, supplier qualification, yield improvement, cost optimization, and lifecycle management.
Support product launches, customer deployments, and post-market engineering activities.
Evaluate emerging technologies in wearable electronics, biosensors, flexible electronics, advanced materials, embedded systems, and connected healthcare.
Contribute to long-term platform strategy and future product roadmaps.
Drive innovation while maintaining practical engineering execution and commercial viability.
Support technology transfer from research and innovation into commercial product development.
Serve as the senior hardware engineering leader within cross-functional product development teams.
Collaborate closely with Product Management, Program Management, Software Engineering, Manufacturing, Clinical, Regulatory, Quality, Commercial, and Executive Leadership.
Provide technical leadership during engineering reviews, regulatory audits, design reviews, and manufacturing readiness assessments.
Ensure engineering priorities remain aligned with customer needs, business objectives, clinical outcomes, and commercialization timelines.