- Company Name
- Shields Group Search
- Job Title
- Biomedical Engineer
- Job Description
-
**Job Title**
Chief Operating Officer / Biomedical Engineering Lead
**Role Summary**
Lead end‑to‑end product development, regulatory strategy, and day‑to‑day operations for a class I/II light‑based wound‑care medical device at an early‑stage medtech company. Drive prototype to commercialization, secure regulatory clearance, and build cross‑functional teams while managing budgets and investor reporting.
**Expectations**
- Design, prototype, and scale a clinically validated device and hydrogel system.
- Secure Health Canada/FDA/CE regulatory submissions and maintain ISO 13485 QMS.
- Operate as senior leader, ensuring project milestones, burn‑rate, and team accountability.
- Translate technical progress into clear investor and stakeholder updates.
- Forge and maintain supplier, CRO, and clinical partner relationships.
**Key Responsibilities**
1. **Device Architecture & Innovation** – Define system integration (optics, electronics, light therapy), ergonomics, and packaging; oversee rapid prototyping and functional validation; plan next‑phase development (e.g., advanced hydrogel cartridges, AI diagnostics).
2. **Regulatory & Clinical Pathway** – Lead Health Canada (or FDA/CE) submissions, coordinate with consultants and CROs, translate technical data into submission‑ready packages, sustain ISO 13485/IEC 60601 compliance.
3. **Operational Leadership** – Manage day‑to‑day operations, delegate engineering and project management tasks, ensure delivery of hardware, AI/ML, and usability testing milestones.
4. **Quality & Risk Management** – Oversee bench‑validation, implement CAPA procedures, map outsourced hydrogel and regulatory outputs to device requirements.
5. **Strategic & Financial Integration** – Tie technical milestones to business outcomes, control budget, burn rate, and resource allocation; prepare KPI‑driven investor reports.
6. **Collaboration & Partnerships** – Build and sustain relationships with universities, CROs, labs, and suppliers; synchronize in‑house and outsourced deliverables.
**Required Skills**
- Hands‑on device design for Class I/II devices from concept to scalable manufacturing.
- Deep knowledge of ISO 13485, IEC 60601, risk management, QMS documentation, and CAPA systems.
- Regulatory submission experience (Health Canada, FDA, or CE).
- Mechanical and electrical system integration, optics, electronics, and hydrogel compatibility.
- Leadership: building, mentoring, and managing multidisciplinary teams (hardware, AI/ML, regulatory, operations).
- Budgeting, burn‑rate monitoring, and investor communication.
- Strong project management, stakeholder coordination, and problem‑solving skills.
**Required Education & Certifications**
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.
- Proven experience with Class I/II medical device development and regulatory clearance.
- Familiarity with ISO 13485 QMS implementation and maintenance.
- Certifications in regulatory affairs or quality management (e.g., Certified Regulatory Affairs Professional, Certified Quality Engineer) are preferred.