Job Specifications
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.
About the Company
Shields Group Search specializes in serving early stage VC and PE backed companies. We offer recruitment and hiring solutions that are industry-agnostic with a particular emphasis on commercial and operational roles. Leveraging tech enabled sourcing and an unwavering commitment to selectivity, our firm identifies and recruits the best candidates to meet your business needs. Backed by a team of seasoned professionals, we ensure confidentiality, quality, and efficiency, in every search, providing our clients with a distinctive...
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