- Company Name
- RBL LLC
- Job Title
- Director, Systems Engineering & Product Lead
- Job Description
-
Job Title: Director, Systems Engineering & Product Lead
Role Summary:
Lead product definition, system architecture, and integration for a complex, regulated medical product platform. Merge systems engineering rigor with product management ownership to translate clinical, user, technical, and business requirements into scalable, executable solutions. Contract duration 1–2 years, with potential senior or director level assignment.
Expectations:
• Deliver end‑to‑end system architecture across device, electronics, software, biologics, and manufacturing.
• Own product definition, target product profile, and user‑centered requirements.
• Serve as cross‑functional technical integrator, driving risk management, verification, and design reviews.
• Manage a small team of engineers and product stakeholders.
• Maintain high‑quality documentation, protocols, and compliance with regulatory standards.
Key Responsibilities:
- Define target product profile, user needs, and system requirements.
- Develop and evolve end‑to‑end system architecture for device, electronics, software, biologics, and manufacturing.
- Lead system‑level integration, design reviews, and technical decision‑making.
- Integrate biologics or combination product components into the overall system design.
- Drive risk management and verification strategy for regulated medical products.
- Act as the cross‑functional technical and product integrator across disciplines.
- Manage a small engineering/product team and mentor junior members.
- Ensure documentation quality, protocol development, and compliance with regulatory requirements.
Required Skills:
- PhD in Biomedical, Mechanical, Electrical Engineering, or related discipline OR 5+ years of relevant industry experience.
- Experience with medical device hardware, electronics, and tissue‑contacting materials.
- Expertise in embedded systems for bioelectronic actuation, control, and communication.
- Firmware and software development experience.
- Mechanical design and modeling capabilities.
- Strong organizational, documentation, and quality control skills.
- Excellent communication and cross‑functional collaboration.
- Proven track record managing a small team.
Required Education & Certifications:
- PhD in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or equivalent.
- OR 5+ years of industry experience in systems engineering, product development, or related roles.
- Certifications in regulatory compliance (e.g., ISO 13485, FDA 21 CFR 820) preferred but not mandatory.