Senior Medical Systems Engineer - Onsite Diagnostics

Werfen; San Diego (CA); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k with employer match

Paid vacation and sick leave

Sales commissions (for applicable role

Performance-based bonus (management/某)

Job summary

Werfen is seeking a Senior System Engineer to join the development team onsite at our Scripps Ranch location. You will define requirements, drive architecture, perform risk analysis, and support integration and testing of complex in vitro diagnostic systems.

You will collaborate with customers, clinicians, vendors, and engineers to ensure product success and regulatory compliance, leading subsystem requirements and design reviews as needed.

Qualifications

• Must have system engineering experience for complex in vitro diagnostic systems.
• Experience delivering products through full development lifecycle for market release.
• Background in medical device development or regulated industries.
• DMAIC experience for improving and stabilizing systems is desirable.
• DOE experience is desirable for developing and optimizing systems.
• Knowledge of UML is desirable for modeling systems.
• Exposure to Human Factors in system design is desirable.

Responsibilities

• Define customer needs and required functionality with product management early in development.
• Create and manage system requirements documentation and architecture.
• Decompose requirements into subsystems and well-defined interfaces.
• Document and manage hazard and risk analysis for projects.
• Develop system error budgets and conduct RM&R analysis.
• Support design reviews and participate in testing strategies for integration.

Skills

System engineering

Medical devices

Regulated industry

Six Sigma DMAIC

DOE

UML

Human factors

Education

BS/BA in CE/EE/ME/Biomedical engineering

Job description

Werfen is seeking a Senior System Engineer to join the development team onsite at our Scripps Ranch location. You will define requirements, drive architecture, perform risk analysis, and support integration and testing of complex in vitro diagnostic systems.

You will collaborate with customers, clinicians, vendors, and engineers to ensure product success and regulatory compliance, leading subsystem requirements and design reviews as needed.