Biomedical Engineer

November 14, 2025

Chief Operating Officer (COO) / Biomedical Engineering LeadLocation: Toronto, ON (On-site, 5 days/week) Early-stage medtech innovator developing next-generation light-based therapeutic devices and hydrogel systems About the CompanyOur client is a pioneering medtech company revolutionizing wound-care technology through a fusion of optics, light therapy, and hydrogel innovation. The team is advancing a patented, clinically validated system designed for emergency, clinical, and at-home use. They are now seeking a COO / Biomedical Engineering Lead to oversee product development, regulatory execution, and operational leadership as the company scales toward commercialization and clinical trials. Key Responsibilities1. Device Development & Innovation<ul><li>Lead device architecture and system integration (optics, ES, light therapy).</li><li>Oversee housing and ergonomic design to ensure usability in emergency, clinical, and consumer settings.</li><li>Ensure compatibility between device mechanics and hydrogel delivery cartridges (specifications set for partners).</li><li>Oversee rapid prototyping and functional validation.</li><li>Foster innovation by planning and initiating next-phase strategies (e.g., advanced hydrogel cartridges, AI wound diagnostics) while ensuring current milestones are executed.</li></ul>2. Regulatory & Clinical Pathway<ul><li>Coordinate with regulatory consultants and CROs for Health Canada submissions and clinical protocols.</li><li>Ensure in-house QMS (ISO 13485 aligned) is maintained to support clearance.</li><li>Act as the corporate lead through regulatory clearance, translating technical results into submission-ready data packages.</li></ul>3. Operational Leadership<ul><li>Act as day-to-day operator, ensuring milestones and deliverables are met.</li><li>Delegate responsibilities to in-house engineers and project managers, ensuring accountability across device hardware, AI integration, and usability testing.</li><li>Build and manage cross-functional internal teams (hardware & AI/ML Engineers).</li><li>Build supplier and partner networks for optics, casing, chips, and clinical collaborations.</li></ul>4. Quality & Risk Management / Clinical Safety Oversight<ul><li>Oversee bench validation of device performance and safety.</li><li>Implement CAPA tracking (Corrective and Preventive Actions) to identify, fix, and prevent recurring issues.</li><li>Ensure outsourced hydrogel and regulatory outputs map back to device requirements.</li></ul>5. Strategic & Financial Integration<ul><li>Link technical milestones to business outcomes (e.g., prototype → milestone-based tranche release).</li><li>Manage budget, burn rate, and resource allocation in line with allocated funding.</li><li>Translate R&D and operational progress into clear investor updates (KPIs, metrics, cost reductions).</li><li>Support the Founder in investor relations by presenting technical feasibility and execution roadmaps.</li></ul>6. Collaboration & Partnerships<ul><li>Foster a culture of innovation and accountability within the in-house team.</li><li>Build strategic collaborations with universities, CROs, and labs for trials and co-development.</li><li>Ensure outsourced and in-house deliverables stay synchronized to decided timelines.</li></ul> Qualifications & Experience<ul><li>Hands-on Device Design Experience – previously led or contributed to the development of Class I/II devices from concept through prototype to scalable manufacturing.</li><li>Regulatory Expertise – direct involvement in Health Canada (or FDA/CE) submissions, with a strong understanding of ISO 13485, IEC 60601, risk management, and QMS documentation.</li><li>Integration Capability – skilled at aligning design-control processes with regulatory requirements, ensuring smooth translation of innovation into compliant, manufacturable products.</li><li>Commercial Awareness – understands how design and regulatory strategy affect timelines, costs, investor confidence, and milestone-based funding releases.</li><li>Network Value – ideally connected to manufacturing, testing, and clinical-trial partners in the medtech ecosystem.</li><li>Leadership Experience – proven ability to build, mentor, and manage cross-functional teams (hardware, AI/ML, regulatory, and operations), delegate effectively, and foster innovation while meeting critical milestones.</li><li>Strategic & Financial Integration – capable of linking R&D and operational progress to business outcomes, investor updates, and burn-rate management.</li><li>Collaboration & Partnerships – demonstrated success in fostering collaborations with CROs, universities, and clinical labs while maintaining accountability across in-house and outsourced teams.</li></ul> Why This RoleThis is a unique opportunity to join a mission-driven medtech startup at the forefront of light-based therapeutics and wound-care innovation. The role combines executive operational leadership with hands-on biomedical engineering — ideal for an experienced operator who thrives at the intersection of device design, regulatory strategy, and commercialization.

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