Systems Engineer

Real Staffing; San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Real Staffing is seeking a Systems Engineer with 3–5 years of experience to translate user needs into rigorous system requirements and to support verification and validation in a regulated medical device environment.

You will collaborate with Regulatory, Marketing, Risk Management, Software, Electrical, and Mechanical teams, drive traceability, and help maintain Design History Files and design reviews throughout the product lifecycle.

Qualifications

• Translate user, business, and stakeholder needs into system requirements.
• Develop strategies for requirements traceability, verification, and validation.
• Maintain technical documentation in regulated environments.
• Identify interfaces, dependencies, and risks in requirements and verification.

Responsibilities

• Gather and translate user, business, and cross-functional stakeholder needs into system and product requirements.
• Develop requirements strategies, traceability, verification methods, and validation plans.
• Author and maintain technical documentation in compliance with medical device design control requirements.
• Identify system interfaces, dependencies, risks, and gaps in requirements or verification evidence.
• Lead and support verification & validation (V&V) activities.
• Partner with Regulatory, Marketing, Risk Management, Software, Electrical, and Mechanical Engineering teams.
• Support Design History Files (DHFs), requirements traceability, and design reviews.
• Drive risk assessments, hazard analysis, and mitigation activities throughout the product lifecycle.

Skills

Systems Engineering

Requirements development

Traceability

Verification & Validation

Technical writing

Regulated environments

Cross-functional teamwork

Requirements translation

Lifecycle knowledge

Job description

Key Responsibilities

• Gather and translate user, business, and cross-functional stakeholder needs into system and product requirements.
• Develop requirements strategies, traceability, verification methods, and validation plans.
• Author and maintain technical documentation in compliance with medical device design control requirements.
• Identify system interfaces, dependencies, risks, and gaps in requirements or verification evidence.
• Lead and support verification & validation (V&V) activities.
• Partner with Regulatory, Marketing, Risk Management, Software, Electrical, and Mechanical Engineering teams.
• Support Design History Files (DHFs), requirements traceability, and design reviews.
• Drive risk assessments, hazard analysis, and mitigation activities throughout the product lifecycle.

Required Qualifications

• 3-5 years of Systems Engineering experience (open to one more senior candidate).
• Experience translating user needs into system requirements.
• Strong understanding of requirements development, traceability, verification, and validation.
• Experience identifying system interfaces, dependencies, and technical risks.
• Strong technical writing and documentation skills.
• Understanding of the full product development lifecycle.
• Experience working in regulated environments and cross-functional teams.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.