Senior Systems Engineer

Pyramid Consulting, Inc; San Diego (CA); On-site; USD 143,270,000 - 171,924,000; Full time

Benefits offered by this job

Health insurance

Job summary

Pyramid Consulting, Inc. is seeking a Senior Systems Engineer for a 6+ month contract in San Diego, CA, onsite. You will translate stakeholder needs into system requirements and manage the development of medical devices or regulated products.

The role requires strong experience in requirements traceability, DFSS, and cross-functional collaboration to ensure FDA audit readiness and successful verification and validation.

Qualifications

• Bachelor’s degree in biomedical, mechanical, or electrical engineering; Master’s/PhD preferred.
• Minimum 5 years as a systems engineer in medical device, aerospace, or defense industries.
• Strong requirements management and traceability experience.
• Experience with DFSS and FDA audit readiness.

Responsibilities

• Translate stakeholder needs into system requirements and design specifications.
• Ensure traceability from needs through verification for FDA audits.
• Lead hazard identification and mitigation.
• Write design verification protocols and conduct design validation.
• Lead feasibility studies and risk assessments for new directions.
• Facilitate cross-functional issue resolution and apply DFSS best practices.

Skills

Systems engineering

Requirements management

DFSS

FDA audit readiness

Education

Bachelor’s degree in engineering/science

Master’s or PhD preferred

Tools

DOORS

TFS

JIRA

JAMA

Confluence

Polarian

Cockpit

Job description

Immediate need for a talented Senior Systems Engineer . This is a 06+ Months Contract opportunity with long-term potential and is located in San Diego, CA (Onsite).

Job ID:26-28726

Pay Range: $50 - $60/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision).

Key Responsibilities:

• Core Function:
• Cross-functional coordination across R&D, quality, regulatory, marketing, and manufacturing to translate stakeholder needs into system/product requirements
• Requirements must follow the V-diagram methodology: Inputs (user needs, regs, hazards) → product requirements → product specifications → Build → verification of specifications → verification of Requirements → Design validation
• Ensure complete traceability from user needs through requirements, specifications, to verification/validation for FDA audit readiness
• Lead hazard identification and mitigation (e.g., pinch points, tip-over risks)
• Key Activities:
• Write design verification protocols and reports proving design outputs meet design inputs
• Conduct design validation to confirm the right product was built to meet actual user needs
• Lead feasibility and risk assessments for new product direction decisions
• Facilitate cross-functional problem resolution when requirements aren't met or reliability issues arise
• Drive continuous process improvements and apply DFSS (Design for Six Sigma) best practices
• Create system architecture documentation including block diagrams and system integration plans

Key Requirements and Technology Experience:

• Bachelor's degree in science/engineering (biomedical, mechanical, or electrical engineering most common); Master's/PhD preferred
• Minimum 5 years as a systems engineer in medical device, aerospace, or defense industries
• Requirements management tools: DOORS, TFS, JIRA, JAMA, Confluence, Polarian, or Cockpit
• Strong requirements traceability experience (not just requirements writing)
• Systems integration and testing expertise (must be well-rounded, not testing-only)
• System architecture planning and design capabilities
• DFSS methodology (design of experiments, root cause analysis, fishbone diagrams)
• Reliability engineering knowledge to collaborate with in-house reliability engineers
• AI experience for process efficiency improvements in requirements writing, traceability, and hazard management
• Ability to communicate technical details to engineers and business concepts to executives
• Strong writing skills for audit-ready documentation
• Extreme attention to detail (every "I dotted, T crossed" for FDA audits)
• Critical Distinctions

Our client is a leading Medical Device Equipment Industry and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.