Biomedical Engineer

Chief Operating Officer (COO) / Biomedical Engineering Lead

Location:
Toronto, ON (On-site, 5 days/week)

Early-stage medtech innovator developing next-generation light-based therapeutic devices and hydrogel systems

About the Company

Our 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 Responsibilities

1. Device Development & Innovation

• Lead device architecture and system integration (optics, ES, light therapy).
• Oversee housing and ergonomic design to ensure usability in emergency, clinical, and consumer settings.
• Ensure compatibility between device mechanics and hydrogel delivery cartridges (specifications set for partners).
• Oversee rapid prototyping and functional validation.
• Foster innovation by planning and initiating next-phase strategies (e.g., advanced hydrogel cartridges, AI wound diagnostics) while ensuring current milestones are executed.

2. Regulatory & Clinical Pathway

• Coordinate with regulatory consultants and CROs for Health Canada submissions and clinical protocols.
• Ensure in-house QMS (ISO 13485 aligned) is maintained to support clearance.
• Act as the corporate lead through regulatory clearance, translating technical results into submission-ready data packages.

3. Operational Leadership

• Act as day-to-day operator, ensuring milestones and deliverables are met.
• Delegate responsibilities to in-house engineers and project managers, ensuring accountability across device hardware, AI integration, and usability testing.
• Build and manage cross-functional internal teams (hardware & AI/ML Engineers).
• Build supplier and partner networks for optics, casing, chips, and clinical collaborations.

4. Quality & Risk Management / Clinical Safety Oversight

• Oversee bench validation of device performance and safety.
• Implement CAPA tracking (Corrective and Preventive Actions) to identify, fix, and prevent recurring issues.
• Ensure outsourced hydrogel and regulatory outputs map back to device requirements.

5. Strategic & Financial Integration

• Link technical milestones to business outcomes (e.g., prototype → milestone-based tranche release).
• Manage budget, burn rate, and resource allocation in line with allocated funding.
• Translate R&D and operational progress into clear investor updates (KPIs, metrics, cost reductions).
• Support the Founder in investor relations by presenting technical feasibility and execution roadmaps.

6. Collaboration & Partnerships

• Foster a culture of innovation and accountability within the in-house team.
• Build strategic collaborations with universities, CROs, and labs for trials and co-development.
• Ensure outsourced and in-house deliverables stay synchronized to decided timelines.

Qualifications & Experience

• Hands-on Device Design Experience
  – previously led or contributed to the development of Class I/II devices from concept through prototype to scalable manufacturing.
• 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.
• Integration Capability
  – skilled at aligning design-control processes with regulatory requirements, ensuring smooth translation of innovation into compliant, manufacturable products.
• Commercial Awareness
  – understands how design and regulatory strategy affect timelines, costs, investor confidence, and milestone-based funding releases.
• Network Value
  – ideally connected to manufacturing, testing, and clinical-trial partners in the medtech ecosystem.
• 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.
• Strategic & Financial Integration
  – capable of linking R&D and operational progress to business outcomes, investor updates, and burn-rate management.
• Collaboration & Partnerships
  – demonstrated success in fostering collaborations with CROs, universities, and clinical labs while maintaining accountability across in-house and outsourced teams.

Why This Role

This 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.