Senior Systems Engineer – Medical Devices & IVD (On-Site)

Ascential Technologies (Instruments and Devices); San Diego (CA); On-site; USD 150,000 - 185,000; Full time

Job summary

Ascential Medical & Life Sciences in San Diego seeks a Senior Systems Engineer to own system-level integration, requirements management, and design verification for complex IVD and medical device programs. You will coordinate cross-functional teams to ensure compliant, manufacturable architectures.

The role requires FDA submissions experience, design controls expertise, and strong leadership to guide subsystems from concept to verification and validation.

Qualifications

• BS in Systems/ Biomedical/ Electrical/ Mechanical Engineering; MS/PhD preferred.
• 8+ years of systems engineering in IVD or human-use medical devices.
• Direct experience with FDA 510(k) and De Novo submissions.
• Deep knowledge of design controls (21 CFR 820.30) and ISO 13485.
• Proven ability to lead requirements, architecture, integration, and verification.

Responsibilities

• Define and maintain system architecture integrating subsystems.
• Own system-level requirements and traceability.
• Lead system-level design reviews, interface control, and ISO 14971 risk analyses.
• Resolve integration issues across use environments.

Skills

Systems engineering

FDA submissions

Requirements management

V&V planning

Leadership

Client interface

Education

BS in Systems/Biomedical/Electrical/Mechanical Engineering

MS or PhD preferred

Tools

Requirements management tools

V&V tooling

Job description

Ascential Medical & Life Sciences in San Diego seeks a Senior Systems Engineer to own system-level integration, requirements management, and design verification for complex IVD and medical device programs. You will coordinate cross-functional teams to ensure compliant, manufacturable architectures.

The role requires FDA submissions experience, design controls expertise, and strong leadership to guide subsystems from concept to verification and validation.