Systems Engineer

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

Job summary

Specialist Staffing Group seeks a Systems Engineer in San Diego, CA, to translate user needs into system requirements and drive V&V in a regulated medical device context.

The role focuses on requirements development, risk assessment, and cross-functional collaboration across Regulatory, Marketing, and Engineering teams, supporting DHFs and design reviews throughout the lifecycle.

Qualifications

• 3-5 years of Systems Engineering experience; higher seniority considered.
• Experience translating user needs into system requirements.
• Strong knowledge of requirements development, traceability, verification, and validation.
• Experience identifying system interfaces, dependencies, and risks.
• Excellent technical writing and documentation abilities.
• Understanding of the full product development lifecycle.
• Experience in regulated environments and cross-functional teams.

Responsibilities

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

Skills

Systems engineering

Translate user needs

Requirements development

Traceability

Verification & Validation

Technical writing

Regulated environments

Job description

• 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.