Senior Systems Engineer (all genders) (full-time, regular)
Core
Senior Systems Engineer leading system architecture, integration, and design controls for aesthetic filler devices and therapeutic combination products in clinical and commercial development.
Role type
Senior IC Systems Engineer (Medical Devices/Combination Products)
Builds
Aesthetic Filler devices, drug delivery systems (syringes, autoinjectors, electromechanical pumps), and combination products for clinical studies and commercial launch.
Domain
Medical Devices / Aesthetics / Drug Delivery Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems Engineering principles, Design Controls (21 CFR 820.30), Risk Management (ISO 14971), DHF management, Requirements definition, Traceability, Change management, Vendor management, Regulatory compliance (FDA/EU MDR)
Preferred skills
Combination product development, Aesthetic Filler product experience, ISO 13485 familiarity
Technologies
FDA 21 CFR Part 820.30, ISO 14971, ISO 13485, EU MDR
Responsibilities
Drive holistic Systems Engineering principles within Design Controls; Define and manage user/stakeholder needs and product requirements; Lead system and use-related risk management activities; Oversee third-party development activities; Collaborate on testing activities and process improvements; Serve as dedicated systems engineer owning key deliverables.
Seniority
Senior, hands-on IC with technical leadership
